The Experts below are selected from a list of 36 Experts worldwide ranked by ideXlab platform

Elie P. Elovic - One of the best experts on this subject based on the ideXlab platform.

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study
    Advances in Therapy, 2019
    Co-Authors: Christina Marciniak, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Jaroslaw Slawek, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    Introduction The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Methods Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. Results A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators ( P  

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study.
    Advances in Therapy, 2018
    Co-Authors: Christina Marciniak, Jarosław Sławek, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators (P 

  • Sustained Efficacy with IncobotulinumtoxinA in Upper-Limb Post-Stroke Spasticity Over 48 Weeks (a Phase 3, Placebo-Controlled Study with an Open-Label Extension) (P3.303)
    Neurology, 2016
    Co-Authors: Elie P. Elovic, Petr Kaňovský, Michael C. Munin, Allison Brashear, Angelika Hanschmann, Reinhard Hiersemenzel, Christina Marciniak
    Abstract:

    Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for upper-limb post-stroke spasticity. Background: Botulinum toxin injections are a recommended treatment for upper-limb spasticity. Data are reported from a 12-week, double-blind, placebo-controlled, Phase 3 study of incobotulinumtoxinA with a 36-week, open-label extension (OLEX) period. Design/Methods: In the placebo-controlled main period (MP), subjects (18-80 years) with upper-limb post-stroke spasticity (wrist, finger, and elbow flexor spasticity ≥2 [Ashworth Scale; AS]) were randomized 2:1 to incobotulinumtoxinA (fixed total dose 400U) or placebo. The OLEX comprised three incobotulinumtoxinA treatments (400U each), each followed by 12 weeks’ observation. Outcomes included AS response (≥1-point improvement from each injection to 4 weeks post-injection) and Disability Assessment Scale (DAS) response (≥1-point improvement in a subject-selected principal target domain [hygiene, dressing, limb position, or pain] from study baseline to 4 weeks post-injection), adverse events (AEs) and antibody testing. Results: In the MP, 317 subjects were randomized; 296 continued into the OLEX. In the MP and OLEX, AS responder rates after each incobotulinumtoxinA treatment were 52.3-61.8[percnt] for wrist flexors, 49.1-60.0[percnt] for elbow flexors, 54.5-64.5[percnt] for finger flexors, 33.9-41.2[percnt] for thumb flexors, and 37.4-44.2[percnt] for Forearm Pronators. DAS responder rates after incobotulinumtoxinA treatment were 46.2[percnt] (MP) and 52.2[percnt], 62.1[percnt], and 59.4[percnt] (OLEX treatment cycles). In the MP, treatment-related AEs were reported for 3.8[percnt] and 1.9[percnt] of subjects for incobotulinumtoxinA and placebo, respectively. The incidence of treatment-related AEs during the entire OLEX was 3.0[percnt] for the 36-week duration. There were no serious treatment-related AEs in the MP or the OLEX, and no clinical non-responsiveness due to antibodies. Conclusions: For subjects with upper-limb spasticity after a stroke, repeated injections of incobotulinumtoxinA (400U each at 12-week intervals) showed sustained efficacy in reducing muscle tone and spasticity-associated disability, while confirming the favorable safety profile of incobotulinumtoxinA in this indication. Disclosure: Dr. Elovic has received personal compensation from Allergan, Inc., and Solstice Neurosciences. Dr. Brashear has received personal compensation for activities with Allergan, Ipsen, Revance and Concerta as a consultant. Dr. Brashear has received royalty payments from books royalties. Dr. Brashear has received research support from Ipsen, Merz, Allerg Dr. Munin has received personal compensation for activities with Merz for Advisory Board participation. Dr. Kaňovský has nothing to disclose. Dr. Hanschmann has received personal compensation for activities with Merz Pharma as an employee. Dr. Hiersemenzel has received personal compensation for activities Merz as an employee. Dr. Marciniak has nothing to disclose.

Christina Marciniak - One of the best experts on this subject based on the ideXlab platform.

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study
    Advances in Therapy, 2019
    Co-Authors: Christina Marciniak, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Jaroslaw Slawek, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    Introduction The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Methods Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. Results A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators ( P  

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study.
    Advances in Therapy, 2018
    Co-Authors: Christina Marciniak, Jarosław Sławek, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators (P 

  • Sustained Efficacy with IncobotulinumtoxinA in Upper-Limb Post-Stroke Spasticity Over 48 Weeks (a Phase 3, Placebo-Controlled Study with an Open-Label Extension) (P3.303)
    Neurology, 2016
    Co-Authors: Elie P. Elovic, Petr Kaňovský, Michael C. Munin, Allison Brashear, Angelika Hanschmann, Reinhard Hiersemenzel, Christina Marciniak
    Abstract:

    Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for upper-limb post-stroke spasticity. Background: Botulinum toxin injections are a recommended treatment for upper-limb spasticity. Data are reported from a 12-week, double-blind, placebo-controlled, Phase 3 study of incobotulinumtoxinA with a 36-week, open-label extension (OLEX) period. Design/Methods: In the placebo-controlled main period (MP), subjects (18-80 years) with upper-limb post-stroke spasticity (wrist, finger, and elbow flexor spasticity ≥2 [Ashworth Scale; AS]) were randomized 2:1 to incobotulinumtoxinA (fixed total dose 400U) or placebo. The OLEX comprised three incobotulinumtoxinA treatments (400U each), each followed by 12 weeks’ observation. Outcomes included AS response (≥1-point improvement from each injection to 4 weeks post-injection) and Disability Assessment Scale (DAS) response (≥1-point improvement in a subject-selected principal target domain [hygiene, dressing, limb position, or pain] from study baseline to 4 weeks post-injection), adverse events (AEs) and antibody testing. Results: In the MP, 317 subjects were randomized; 296 continued into the OLEX. In the MP and OLEX, AS responder rates after each incobotulinumtoxinA treatment were 52.3-61.8[percnt] for wrist flexors, 49.1-60.0[percnt] for elbow flexors, 54.5-64.5[percnt] for finger flexors, 33.9-41.2[percnt] for thumb flexors, and 37.4-44.2[percnt] for Forearm Pronators. DAS responder rates after incobotulinumtoxinA treatment were 46.2[percnt] (MP) and 52.2[percnt], 62.1[percnt], and 59.4[percnt] (OLEX treatment cycles). In the MP, treatment-related AEs were reported for 3.8[percnt] and 1.9[percnt] of subjects for incobotulinumtoxinA and placebo, respectively. The incidence of treatment-related AEs during the entire OLEX was 3.0[percnt] for the 36-week duration. There were no serious treatment-related AEs in the MP or the OLEX, and no clinical non-responsiveness due to antibodies. Conclusions: For subjects with upper-limb spasticity after a stroke, repeated injections of incobotulinumtoxinA (400U each at 12-week intervals) showed sustained efficacy in reducing muscle tone and spasticity-associated disability, while confirming the favorable safety profile of incobotulinumtoxinA in this indication. Disclosure: Dr. Elovic has received personal compensation from Allergan, Inc., and Solstice Neurosciences. Dr. Brashear has received personal compensation for activities with Allergan, Ipsen, Revance and Concerta as a consultant. Dr. Brashear has received royalty payments from books royalties. Dr. Brashear has received research support from Ipsen, Merz, Allerg Dr. Munin has received personal compensation for activities with Merz for Advisory Board participation. Dr. Kaňovský has nothing to disclose. Dr. Hanschmann has received personal compensation for activities with Merz Pharma as an employee. Dr. Hiersemenzel has received personal compensation for activities Merz as an employee. Dr. Marciniak has nothing to disclose.

Reinhard Hiersemenzel - One of the best experts on this subject based on the ideXlab platform.

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study
    Advances in Therapy, 2019
    Co-Authors: Christina Marciniak, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Jaroslaw Slawek, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    Introduction The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Methods Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. Results A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators ( P  

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study.
    Advances in Therapy, 2018
    Co-Authors: Christina Marciniak, Jarosław Sławek, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators (P 

  • Sustained Efficacy with IncobotulinumtoxinA in Upper-Limb Post-Stroke Spasticity Over 48 Weeks (a Phase 3, Placebo-Controlled Study with an Open-Label Extension) (P3.303)
    Neurology, 2016
    Co-Authors: Elie P. Elovic, Petr Kaňovský, Michael C. Munin, Allison Brashear, Angelika Hanschmann, Reinhard Hiersemenzel, Christina Marciniak
    Abstract:

    Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for upper-limb post-stroke spasticity. Background: Botulinum toxin injections are a recommended treatment for upper-limb spasticity. Data are reported from a 12-week, double-blind, placebo-controlled, Phase 3 study of incobotulinumtoxinA with a 36-week, open-label extension (OLEX) period. Design/Methods: In the placebo-controlled main period (MP), subjects (18-80 years) with upper-limb post-stroke spasticity (wrist, finger, and elbow flexor spasticity ≥2 [Ashworth Scale; AS]) were randomized 2:1 to incobotulinumtoxinA (fixed total dose 400U) or placebo. The OLEX comprised three incobotulinumtoxinA treatments (400U each), each followed by 12 weeks’ observation. Outcomes included AS response (≥1-point improvement from each injection to 4 weeks post-injection) and Disability Assessment Scale (DAS) response (≥1-point improvement in a subject-selected principal target domain [hygiene, dressing, limb position, or pain] from study baseline to 4 weeks post-injection), adverse events (AEs) and antibody testing. Results: In the MP, 317 subjects were randomized; 296 continued into the OLEX. In the MP and OLEX, AS responder rates after each incobotulinumtoxinA treatment were 52.3-61.8[percnt] for wrist flexors, 49.1-60.0[percnt] for elbow flexors, 54.5-64.5[percnt] for finger flexors, 33.9-41.2[percnt] for thumb flexors, and 37.4-44.2[percnt] for Forearm Pronators. DAS responder rates after incobotulinumtoxinA treatment were 46.2[percnt] (MP) and 52.2[percnt], 62.1[percnt], and 59.4[percnt] (OLEX treatment cycles). In the MP, treatment-related AEs were reported for 3.8[percnt] and 1.9[percnt] of subjects for incobotulinumtoxinA and placebo, respectively. The incidence of treatment-related AEs during the entire OLEX was 3.0[percnt] for the 36-week duration. There were no serious treatment-related AEs in the MP or the OLEX, and no clinical non-responsiveness due to antibodies. Conclusions: For subjects with upper-limb spasticity after a stroke, repeated injections of incobotulinumtoxinA (400U each at 12-week intervals) showed sustained efficacy in reducing muscle tone and spasticity-associated disability, while confirming the favorable safety profile of incobotulinumtoxinA in this indication. Disclosure: Dr. Elovic has received personal compensation from Allergan, Inc., and Solstice Neurosciences. Dr. Brashear has received personal compensation for activities with Allergan, Ipsen, Revance and Concerta as a consultant. Dr. Brashear has received royalty payments from books royalties. Dr. Brashear has received research support from Ipsen, Merz, Allerg Dr. Munin has received personal compensation for activities with Merz for Advisory Board participation. Dr. Kaňovský has nothing to disclose. Dr. Hanschmann has received personal compensation for activities with Merz Pharma as an employee. Dr. Hiersemenzel has received personal compensation for activities Merz as an employee. Dr. Marciniak has nothing to disclose.

Angelika Hanschmann - One of the best experts on this subject based on the ideXlab platform.

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study
    Advances in Therapy, 2019
    Co-Authors: Christina Marciniak, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Jaroslaw Slawek, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    Introduction The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Methods Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. Results A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators ( P  

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study.
    Advances in Therapy, 2018
    Co-Authors: Christina Marciniak, Jarosław Sławek, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators (P 

  • Sustained Efficacy with IncobotulinumtoxinA in Upper-Limb Post-Stroke Spasticity Over 48 Weeks (a Phase 3, Placebo-Controlled Study with an Open-Label Extension) (P3.303)
    Neurology, 2016
    Co-Authors: Elie P. Elovic, Petr Kaňovský, Michael C. Munin, Allison Brashear, Angelika Hanschmann, Reinhard Hiersemenzel, Christina Marciniak
    Abstract:

    Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for upper-limb post-stroke spasticity. Background: Botulinum toxin injections are a recommended treatment for upper-limb spasticity. Data are reported from a 12-week, double-blind, placebo-controlled, Phase 3 study of incobotulinumtoxinA with a 36-week, open-label extension (OLEX) period. Design/Methods: In the placebo-controlled main period (MP), subjects (18-80 years) with upper-limb post-stroke spasticity (wrist, finger, and elbow flexor spasticity ≥2 [Ashworth Scale; AS]) were randomized 2:1 to incobotulinumtoxinA (fixed total dose 400U) or placebo. The OLEX comprised three incobotulinumtoxinA treatments (400U each), each followed by 12 weeks’ observation. Outcomes included AS response (≥1-point improvement from each injection to 4 weeks post-injection) and Disability Assessment Scale (DAS) response (≥1-point improvement in a subject-selected principal target domain [hygiene, dressing, limb position, or pain] from study baseline to 4 weeks post-injection), adverse events (AEs) and antibody testing. Results: In the MP, 317 subjects were randomized; 296 continued into the OLEX. In the MP and OLEX, AS responder rates after each incobotulinumtoxinA treatment were 52.3-61.8[percnt] for wrist flexors, 49.1-60.0[percnt] for elbow flexors, 54.5-64.5[percnt] for finger flexors, 33.9-41.2[percnt] for thumb flexors, and 37.4-44.2[percnt] for Forearm Pronators. DAS responder rates after incobotulinumtoxinA treatment were 46.2[percnt] (MP) and 52.2[percnt], 62.1[percnt], and 59.4[percnt] (OLEX treatment cycles). In the MP, treatment-related AEs were reported for 3.8[percnt] and 1.9[percnt] of subjects for incobotulinumtoxinA and placebo, respectively. The incidence of treatment-related AEs during the entire OLEX was 3.0[percnt] for the 36-week duration. There were no serious treatment-related AEs in the MP or the OLEX, and no clinical non-responsiveness due to antibodies. Conclusions: For subjects with upper-limb spasticity after a stroke, repeated injections of incobotulinumtoxinA (400U each at 12-week intervals) showed sustained efficacy in reducing muscle tone and spasticity-associated disability, while confirming the favorable safety profile of incobotulinumtoxinA in this indication. Disclosure: Dr. Elovic has received personal compensation from Allergan, Inc., and Solstice Neurosciences. Dr. Brashear has received personal compensation for activities with Allergan, Ipsen, Revance and Concerta as a consultant. Dr. Brashear has received royalty payments from books royalties. Dr. Brashear has received research support from Ipsen, Merz, Allerg Dr. Munin has received personal compensation for activities with Merz for Advisory Board participation. Dr. Kaňovský has nothing to disclose. Dr. Hanschmann has received personal compensation for activities with Merz Pharma as an employee. Dr. Hiersemenzel has received personal compensation for activities Merz as an employee. Dr. Marciniak has nothing to disclose.

Allison Brashear - One of the best experts on this subject based on the ideXlab platform.

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study
    Advances in Therapy, 2019
    Co-Authors: Christina Marciniak, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Jaroslaw Slawek, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    Introduction The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Methods Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. Results A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators ( P  

  • IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study.
    Advances in Therapy, 2018
    Co-Authors: Christina Marciniak, Jarosław Sławek, Michael C. Munin, Allison Brashear, Bruce S. Rubin, Atul T. Patel, Angelika Hanschmann, Reinhard Hiersemenzel, Elie P. Elovic
    Abstract:

    The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Adults 18–80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinumtoxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the respective 4-week post-injection visit ranged by cycle from 52.3% to 59.2% for wrist flexors, 49.1% to 52.3% for elbow flexors, 59.8% to 64.5% for finger flexors, 35.5% to 41.2% for thumb flexors, and 37.4% to 39.9% for Forearm Pronators (P 

  • Sustained Efficacy with IncobotulinumtoxinA in Upper-Limb Post-Stroke Spasticity Over 48 Weeks (a Phase 3, Placebo-Controlled Study with an Open-Label Extension) (P3.303)
    Neurology, 2016
    Co-Authors: Elie P. Elovic, Petr Kaňovský, Michael C. Munin, Allison Brashear, Angelika Hanschmann, Reinhard Hiersemenzel, Christina Marciniak
    Abstract:

    Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for upper-limb post-stroke spasticity. Background: Botulinum toxin injections are a recommended treatment for upper-limb spasticity. Data are reported from a 12-week, double-blind, placebo-controlled, Phase 3 study of incobotulinumtoxinA with a 36-week, open-label extension (OLEX) period. Design/Methods: In the placebo-controlled main period (MP), subjects (18-80 years) with upper-limb post-stroke spasticity (wrist, finger, and elbow flexor spasticity ≥2 [Ashworth Scale; AS]) were randomized 2:1 to incobotulinumtoxinA (fixed total dose 400U) or placebo. The OLEX comprised three incobotulinumtoxinA treatments (400U each), each followed by 12 weeks’ observation. Outcomes included AS response (≥1-point improvement from each injection to 4 weeks post-injection) and Disability Assessment Scale (DAS) response (≥1-point improvement in a subject-selected principal target domain [hygiene, dressing, limb position, or pain] from study baseline to 4 weeks post-injection), adverse events (AEs) and antibody testing. Results: In the MP, 317 subjects were randomized; 296 continued into the OLEX. In the MP and OLEX, AS responder rates after each incobotulinumtoxinA treatment were 52.3-61.8[percnt] for wrist flexors, 49.1-60.0[percnt] for elbow flexors, 54.5-64.5[percnt] for finger flexors, 33.9-41.2[percnt] for thumb flexors, and 37.4-44.2[percnt] for Forearm Pronators. DAS responder rates after incobotulinumtoxinA treatment were 46.2[percnt] (MP) and 52.2[percnt], 62.1[percnt], and 59.4[percnt] (OLEX treatment cycles). In the MP, treatment-related AEs were reported for 3.8[percnt] and 1.9[percnt] of subjects for incobotulinumtoxinA and placebo, respectively. The incidence of treatment-related AEs during the entire OLEX was 3.0[percnt] for the 36-week duration. There were no serious treatment-related AEs in the MP or the OLEX, and no clinical non-responsiveness due to antibodies. Conclusions: For subjects with upper-limb spasticity after a stroke, repeated injections of incobotulinumtoxinA (400U each at 12-week intervals) showed sustained efficacy in reducing muscle tone and spasticity-associated disability, while confirming the favorable safety profile of incobotulinumtoxinA in this indication. Disclosure: Dr. Elovic has received personal compensation from Allergan, Inc., and Solstice Neurosciences. Dr. Brashear has received personal compensation for activities with Allergan, Ipsen, Revance and Concerta as a consultant. Dr. Brashear has received royalty payments from books royalties. Dr. Brashear has received research support from Ipsen, Merz, Allerg Dr. Munin has received personal compensation for activities with Merz for Advisory Board participation. Dr. Kaňovský has nothing to disclose. Dr. Hanschmann has received personal compensation for activities with Merz Pharma as an employee. Dr. Hiersemenzel has received personal compensation for activities Merz as an employee. Dr. Marciniak has nothing to disclose.