A Phase 4 interventional study of Botulinum toxin type A and GSC in Spastic Hemiparesis, sponsored by Ipsen. Completed at 19 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Ipsen · Phase 4, Interventional, and Treatment
The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.
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Each subject will undergo two intramuscular injection (treatment) cycles, receiving AbobotulinumtoxinA (Dysport®) 1500 U on Day 1 of each cycle; the two dosing occasions will be separated by at least 12 weeks (maximum 20 weeks). Subjects will also receive daily GSC therapy. The main focus of GSC will be on the primary treatment target (TT) limb (as determined at the Baseline Visit) and then the other limb. All muscle groups requiring active training and/or stretching should be trained. Subjects will be be given a diary to record each day whether they have performed the GSC therapy.
Biological: Botulinum toxin type A · Other: GSC
Dysport® administered in both upper and lower limbs (total dose of 1500 U per injection split between the 2 limbs).
Also known as: AbobotulinumtoxinA (Dysport®)
The GSC is a motivational tool. The physiotherapist will teach each subject the stretching postures and exercises to perform on a daily basis throughout the study. These will be tailored to the individual subject's needs and will form the GSC therapy.
Percentage of Responder Participants at Week 6 After the Second Injection, According to Composite Active Range of Motion (AROM) in the Primary TT Limb
Percentage of responder participants according to AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the second injection).
Time frame: At Week 6, Cycle 2
Percentage of Responder Participants at Week 6 After the First Injection, According to Composite AROM in the Primary TT Limb
Percentage of responder participants according to composite AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the first injection).
Time frame: At Week 6, Cycle 1
Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit
The AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. The angle of joint movement was measured in 10 prespecified muscle groups (injected or noninjected); UL: shoulder extensors (SE), elbow flexors (EF), wrist flexors (WF), extrinsic finger flexors (FF) and pronator teres (PT), LL: soleus (Sol), gastrocnemius (GN), gluteus maximus (GM), hamstrings (HS) and rectus femoris (RF). The reinjection cycle visit corresponds to Week 12, 16 or 20 of injection Cycle 1. The last study visit corresponds to the last post-baseline visit performed by the participant (including the early withdrawal visit).
Time frame: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit
Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit
Composite AROM (XA) was measured by goniometer in the primary TT limb (either UL or LL, depending on which one has been selected as the primary TT limb), composite AROM in the UL injected muscle groups was calculated as the sum of the AROM in the EF, WF and FF. Composite AROM in the LL injected muscle groups was calculated as the sum of the AROM in Sol and GN.
Time frame: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit
Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit
Full composite AROM, regardless of whether the muscle groups was injected or not was measured by goniometer in the primary TT limb. Full Composite AROM in the UL was calculated as the sum of the AROM in the 5 UL muscle groups (SE+EF+WF+FF+PT). Full Composite AROM in the LL was calculated as the sum of the AROM in the 5 LL muscle groups (Sol+GN+GM+HS+RF).
Time frame: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit
Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score Evaluated Locally and Centrally at Week 12 of Each Treatment Cycle and Last Study Visit
The MFS was used to measure active function in the UL. The MFS consists of 10 tasks, each of which was evaluated locally by the site investigator and centrally by a blinded central reviewer at the coordinating investigators' site, on a 10-point visual analogue scale (VAS) ranging from "No movement" to "Normal". Higher score indicates a better outcome. The MFS overall scores were obtained by averaging all individual task scores, provided that at least 8 out of the 10 were not missing. The mean change from baseline was calculated for the local and central assessments and a positive change from baseline indicates an improvement in active function.
Time frame: Week 12 of each treatment cycle and last study visit
Mean Change From Baseline in Maximal Walking Speed Barefoot at Week 12 of Each Treatment Cycle and at Last Study Visit
The 10-meter walking speed test (WST) was used to measure active function in the LL. The participant performed the WST barefoot without a walking aid. If it was absolutely necessary that the participant used a cane, this may have been permitted provided that the same cane was used at baseline and all other walking speed assessments for that participant. The participant was given instructions to walk at his/her maximum speed. The time taken for the participant to walk from the start to the end of the 10 meters was recorded.
Time frame: Week 12 of each treatment cycle and last study visit
Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit
Each participant received a personalised rehabilitation programme. The physiotherapist taught each participant the stretching postures and exercises to perform on a daily basis throughout the study. These were tailored to the individual participant's needs and formed the GSC therapy. The main focus was on the primary TT limb and then the other limb. Participant satisfaction was determined by asking the question "How satisfied are you TODAY regarding the GSC?" Responses were recorded using a 5-level Likert scale, as follows: completely satisfied (+2), rather satisfied (+1), neither satisfied nor dissatisfied (0), rather dissatisfied (-1), and completely dissatisfied (-2).
Time frame: At baseline (for participants who had GSC previously only), Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit
Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit
Participants were asked the following question: "Do you believe that GSC will help to improve your arm and leg function?" Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2).
Time frame: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit
Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit
Physiotherapists were asked the following question: "Do you believe that GSC will help to improve your patient's arm and leg function?" Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2).
Time frame: Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit
Percentage of Days Over Study Period When GSC Therapy Was Performed
The investigator counted the number of days when GSC therapy was not performed since the last visit. Using the total number of study days and the total number of days when GSC therapy was not performed, the number of days when GSC was performed was calculated.
Time frame: From baseline to end of the study, up to 280 days
Global Assessment of Benefits of the Study Therapy
A global assessment of the benefits of the study therapy was made by the investigator and the participant (or the caregiver). The participant's caregiver performed the global assessment only in those cases when the participant was not capable to do this. Participants were asked the following question: "How would you rate the overall response to study therapy since baseline?" Responses on the global assessment were recorded on a 5-level Likert scale, as follows: much better (+2), a bit better (+1), the same (0), a bit worse (-1), and much worse (-2).
Time frame: At reinjection cycle visit (Week 12, 16 or 20) and last study visit (Week 24 or 40)
Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles
Participants who were not reinjected at Week 12 of a given cycle, recorded their satisfaction with a longer interval between 2 injections collected at the corresponding reinjection visit or the last cycle visit (Week 16 or Week 20 for each cycle). To assess this, the participants were asked the following question: "Are you satisfied with a longer interval between 2 injections?". The possible answers were: Yes, No or No opinion.
Time frame: At reinjection cycle visit (Week 16 or 20) and last study visit (Week 24 or 40)
Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit
Participants were asked to complete EQ-5D-5L questionnaire to assess their current health status. The EQ-5D-5L was a generic, preference-based measure of health-related quality of life (QoL). Questions were answered based on how the participant was feeling "Today". The EQ-5D-5L consists of 2 parts: EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system included questions for each of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS recorded participant's self-rated health on a vertical 20-centimeter VAS where the endpoints were labelled "The best health you can imagine" and "The worst health you can imagine". The EQ-5D-5L questionnaire scores range from 0-100, where 0= worst self-perceived health and 100= best self-perceived health. Positive change from baseline indicates an improvement in QoL.
Time frame: At last study visit (Week 24 or 40)
Change From Baseline in Short Form 12 (SF-12) Scales at Last Study Visit
The SF-12 was a short form questionnaire survey consisting of 12 questions, which were a subset of the SF-36 health survey. Most of the questions were answered based on how the participant had felt over the previous 4 weeks. The SF-12 covers 8 domains, including physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional and mental health. The SF-12 questionnaire survey scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Positive change from baseline indicates an improvement in QoL.
Time frame: At last study visit (Week 24 or 40)
This multicenter, single-arm study was conducted in 18 centers in 4 countries between 22 December 2016 and 18 July 2018 in participants with spastic hemiparesis due to acquired brain injury. Study had 2 treatment cycles separated by at least 12 (maximum 20) weeks and combined with Guided Self-Rehabilitation Contract (GSC) for whole study duration.
| Milestone | Dysport |
|---|---|
| Started | 157 |
| Intent-to-treat (itt) population | 153 |
| Completed | 134 |
| Not completed | 23 |
| Withdrew: Adverse event | 7 |
| Withdrew: Consent withdrawn | 2 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Did not need to be reinjected | 6 |
| Withdrew: Personal reasons | 5 |
Percentage of responder participants according to AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the second injection).
| percentage of participants | Dysport |
|---|---|
| Percentage of Responder Participants at Week 6 After the Second Injection, According to Composite Active Range of Motion (AROM) in the Primary TT Limb | 72.1 (64.0 to 78.9) |
Percentage of responder participants according to composite AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the first injection).
| percentage of participants | Dysport |
|---|---|
| Percentage of Responder Participants at Week 6 After the First Injection, According to Composite AROM in the Primary TT Limb | 58.2 (50.2 to 65.7) |
The AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. The angle of joint movement was measured in 10 prespecified muscle groups (injected or noninjected); UL: shoulder extensors (SE), elbow flexors (EF), wrist flexors (WF), extrinsic finger flexors (FF) and pronator teres (PT), LL: soleus (Sol), gastrocnemius (GN), gluteus maximus (GM), hamstrings (HS) and rectus femoris (RF). The reinjection cycle visit corresponds to Week 12, 16 or 20 of injection Cycle 1. The last study visit corresponds to the last post-baseline visit performed by the participant (including the early withdrawal visit).
| degrees | Dysport |
|---|---|
| UL SE: Week 6, Cycle 1 | 8.9 ± 16.4 |
| UL SE: Week 12, Cycle 1 | 15.8 ± 22.9 |
| UL SE: Reinjection cycle visit | 13.4 ± 22.5 |
| UL SE: Week 6, Cycle 2 | 19.3 ± 25.1 |
| UL SE: Week 12, Cycle 2 | 21.1 ± 27.7 |
| UL SE: Last study visit | 19.0 ± 24.9 |
| UL EF: Week 6, Cycle 1 | 8.7 ± 25.5 |
| UL EF: Week 12, Cycle 1 | 12.0 ± 27.3 |
| UL EF: Reinjection cycle visit | 10.9 ± 28.3 |
| UL EF: Week 6, Cycle 2 | 14.9 ± 26.2 |
| UL EF: Week 12, Cycle 2 | 15.4 ± 28.1 |
| UL EF: Last study visit | 13.0 ± 28.2 |
| UL WF: Week 6, Cycle 1 | 11.0 ± 16.3 |
| UL WF: Week 12, Cycle 1 | 10.9 ± 20.1 |
| UL WF: Reinjection cycle visit | 9.6 ± 20.4 |
| UL WF: Week 6, Cycle 2 | 15.6 ± 24.3 |
| UL WF: Week 12, Cycle 2 | 13.6 ± 22.4 |
| UL WF: Last study visit | 12.4 ± 22.3 |
| UL FF: Week 6, Cycle 1 | 24.1 ± 37.1 |
| UL FF: Week 12, Cycle 1 | 20.7 ± 36.0 |
| UL FF: Reinjection cycle visit | 14.5 ± 36.7 |
| UL FF: Week 6, Cycle 2 | 29.5 ± 43.7 |
| UL FF: Week 12, Cycle 2 | 27.9 ± 49.1 |
| UL FF: Last study visit | 24.5 ± 44.9 |
| UL PT: Week 6, Cycle 1 | 9.0 ± 32.6 |
| UL PT: Week 12, Cycle 1 | 8.0 ± 38.0 |
| UL PT: Reinjection cycle visit | 7.4 ± 37.9 |
| UL PT: Week 6, Cycle 2 | 11.0 ± 38.6 |
| UL PT: Week 12, Cycle 2 | 9.4 ± 38.4 |
| UL PT: Last study visit | 8.7 ± 41.0 |
| LL Sol: Week 6, Cycle 1 | 4.7 ± 9.6 |
| LL Sol: Week 12, Cycle 1 | 5.2 ± 13.8 |
| LL Sol: Reinjection cycle visit | 4.5 ± 15.4 |
| LL Sol: Week 6, Cycle 2 | 9.3 ± 17.9 |
| LL Sol: Week 12, Cycle 2 | 9.0 ± 17.0 |
| LL Sol: Last study visit | 8.2 ± 16.4 |
| LL GN: Week 6, Cycle 1 | 9.0 ± 14.8 |
| LL GN: Week 12, Cycle 1 | 9.9 ± 14.6 |
| LL GN: Reinjection cycle visit | 7.5 ± 15.0 |
| LL GN: Week 6, Cycle 2 | 12.6 ± 16.8 |
| LL GN: Week 12, Cycle 2 | 11.8 ± 17.1 |
| LL GN: Last study visit | 11.9 ± 17.4 |
| LL GM: Week 6, Cycle 1 | 5.1 ± 15.9 |
| LL GM: Week 12, Cycle 1 | 5.2 ± 15.2 |
| LL GM: Reinjection cycle visit | 5.1 ± 14.7 |
| LL GM: Week 6, Cycle 2 | 6.1 ± 15.9 |
| LL GM: Week 12, Cycle 2 | 7.3 ± 15.2 |
| LL GM: Last study visit | 6.6 ± 16.5 |
| LL HS: Week 6, Cycle 1 | 0.9 ± 34.2 |
| LL HS: Week 12, Cycle 1 | 4.0 ± 34.7 |
| LL HS: Reinjection cycle visit | 5.6 ± 30.7 |
| LL HS: Week 6, Cycle 2 | 8.2 ± 25.1 |
| LL HS: Week 12, Cycle 2 | 10.3 ± 26.3 |
| LL HS: Last study visit | 6.8 ± 31.1 |
| LL RF: Week 6, Cycle 1 | 4.5 ± 15.0 |
| LL RF: Week 12, Cycle 1 | 4.4 ± 23.1 |
| LL RF: Reinjection cycle visit | 5.1 ± 25.3 |
| LL RF: Week 6, Cycle 2 | 8.9 ± 24.7 |
| LL RF: Week 12, Cycle 2 | 9.6 ± 23.4 |
| LL RF: Last study visit | 8.6 ± 23.0 |
Composite AROM (XA) was measured by goniometer in the primary TT limb (either UL or LL, depending on which one has been selected as the primary TT limb), composite AROM in the UL injected muscle groups was calculated as the sum of the AROM in the EF, WF and FF. Composite AROM in the LL injected muscle groups was calculated as the sum of the AROM in Sol and GN.
| degrees | Dysport |
|---|---|
| UL: Week 6, Cycle 1 | 43.1 ± 49.9 |
| UL: Week 12, Cycle 1 | 42.8 ± 56.7 |
| UL: Reinjection cycle visit | 34.1 ± 52.8 |
| UL: Week 6, Cycle 2 | 59.5 ± 64.4 |
| UL: Week 12, Cycle 2 | 56.3 ± 66.7 |
| UL: Last study visit | 49.3 ± 63.4 |
| LL: Week 6, Cycle 1 | 13.7 ± 18.3 |
| LL: Week 12, Cycle 1 | 15.1 ± 23.4 |
| LL: Reinjection cycle visit | 12.0 ± 24.5 |
| LL: Week 6, Cycle 2 | 21.9 ± 28.8 |
| LL: Week 12, Cycle 2 | 20.8 ± 28.8 |
| LL: Last study visit | 20.1 ± 27.6 |
Full composite AROM, regardless of whether the muscle groups was injected or not was measured by goniometer in the primary TT limb. Full Composite AROM in the UL was calculated as the sum of the AROM in the 5 UL muscle groups (SE+EF+WF+FF+PT). Full Composite AROM in the LL was calculated as the sum of the AROM in the 5 LL muscle groups (Sol+GN+GM+HS+RF).
| degrees | Dysport |
|---|---|
| UL: Week 6, Cycle 1 | 60.6 ± 68.4 |
| UL: Week 12, Cycle 1 | 66.3 ± 75.7 |
| UL: Reinjection cycle visit | 53.9 ± 69.9 |
| UL: Week 6, Cycle 2 | 90.5 ± 90.1 |
| UL: Week 12, Cycle 2 | 87.6 ± 94.8 |
| UL: Last study visit | 77.8 ± 89.6 |
| LL: Week 6, Cycle 1 | 24.4 ± 42.7 |
| LL: Week 12, Cycle 1 | 28.7 ± 55.9 |
| LL: Reinjection cycle visit | 28.0 ± 56.2 |
| LL: Week 6, Cycle 2 | 45.1 ± 58.2 |
| LL: Week 12, Cycle 2 | 48.1 ± 60.4 |
| LL: Last study visit | 42.2 ± 61.7 |
The MFS was used to measure active function in the UL. The MFS consists of 10 tasks, each of which was evaluated locally by the site investigator and centrally by a blinded central reviewer at the coordinating investigators' site, on a 10-point visual analogue scale (VAS) ranging from "No movement" to "Normal". Higher score indicates a better outcome. The MFS overall scores were obtained by averaging all individual task scores, provided that at least 8 out of the 10 were not missing. The mean change from baseline was calculated for the local and central assessments and a positive change from baseline indicates an improvement in active function.
| units on a scale | Dysport |
|---|---|
| Local assessment: Week 12, Cycle 1 | 0.44 ± 0.56 |
| Local assessment: Week 12, Cycle 2 | 0.55 ± 0.65 |
| Local assessment: Last study visit | 0.53 ± 0.63 |
| Central assessment: Week 12, Cycle 1 | 0.08 ± 0.49 |
| Central assessment: Week 12, Cycle 2 | 0.18 ± 0.61 |
| Central assessment: Last study visit | 0.14 ± 0.59 |
The 10-meter walking speed test (WST) was used to measure active function in the LL. The participant performed the WST barefoot without a walking aid. If it was absolutely necessary that the participant used a cane, this may have been permitted provided that the same cane was used at baseline and all other walking speed assessments for that participant. The participant was given instructions to walk at his/her maximum speed. The time taken for the participant to walk from the start to the end of the 10 meters was recorded.
| meters per second | Dysport |
|---|---|
| Week 12, Cycle 1 | 0.081 ± 0.161 |
| Week 12, Cycle 2 | 0.116 ± 0.159 |
| Last study visit | 0.097 ± 0.187 |
Each participant received a personalised rehabilitation programme. The physiotherapist taught each participant the stretching postures and exercises to perform on a daily basis throughout the study. These were tailored to the individual participant's needs and formed the GSC therapy. The main focus was on the primary TT limb and then the other limb. Participant satisfaction was determined by asking the question "How satisfied are you TODAY regarding the GSC?" Responses were recorded using a 5-level Likert scale, as follows: completely satisfied (+2), rather satisfied (+1), neither satisfied nor dissatisfied (0), rather dissatisfied (-1), and completely dissatisfied (-2).
| units on a scale | Dysport |
|---|---|
| Baseline for non-naïve participants to GSC only | 1.8 ± 0.5 |
| Week 6, Cycle 1 | 1.3 ± 0.9 |
| Week 12, Cycle 1 | 1.4 ± 0.8 |
| Reinjection cycle visit | 1.4 ± 0.7 |
| Week 6, Cycle 2 | 1.4 ± 0.7 |
| Week 12, Cycle 2 | 1.4 ± 0.8 |
| Last study visit | 1.4 ± 0.8 |
Participants were asked the following question: "Do you believe that GSC will help to improve your arm and leg function?" Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2).
| units on a scale | Dysport |
|---|---|
| Week 6, Cycle 1 | -0.2 ± 0.9 |
| Week 12, Cycle 1 | -0.1 ± 0.8 |
| Reinjection cycle visit | -0.2 ± 0.8 |
| Week 6, Cycle 2 | -0.1 ± 0.7 |
| Week 12, Cycle 2 | -0.3 ± 0.8 |
| Last study visit | -0.2 ± 0.8 |
Physiotherapists were asked the following question: "Do you believe that GSC will help to improve your patient's arm and leg function?" Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2).
| units on a scale | Dysport |
|---|---|
| Week 6, Cycle 1 | -0.2 ± 0.6 |
| Week 12, Cycle 1 | -0.2 ± 0.6 |
| Reinjection cycle visit | -0.1 ± 0.6 |
| Week 6, Cycle 2 | -0.2 ± 0.6 |
| Week 12, Cycle 2 | -0.2 ± 0.6 |
| Last study visit | -0.2 ± 0.7 |
The investigator counted the number of days when GSC therapy was not performed since the last visit. Using the total number of study days and the total number of days when GSC therapy was not performed, the number of days when GSC was performed was calculated.
| percentage of study days | Dysport |
|---|---|
| Percentage of Days Over Study Period When GSC Therapy Was Performed | 92.80 ± 9.85 |
A global assessment of the benefits of the study therapy was made by the investigator and the participant (or the caregiver). The participant's caregiver performed the global assessment only in those cases when the participant was not capable to do this. Participants were asked the following question: "How would you rate the overall response to study therapy since baseline?" Responses on the global assessment were recorded on a 5-level Likert scale, as follows: much better (+2), a bit better (+1), the same (0), a bit worse (-1), and much worse (-2).
| units on a scale | Dysport |
|---|---|
| Investigator: Reinjection cycle visit | 1.4 ± 0.6 |
| Investigator: Last study visit | 1.3 ± 0.7 |
| Participant: Reinjection cycle visit | 1.4 ± 0.6 |
| Participant: Last study visit | 1.4 ± 0.7 |
Participants who were not reinjected at Week 12 of a given cycle, recorded their satisfaction with a longer interval between 2 injections collected at the corresponding reinjection visit or the last cycle visit (Week 16 or Week 20 for each cycle). To assess this, the participants were asked the following question: "Are you satisfied with a longer interval between 2 injections?". The possible answers were: Yes, No or No opinion.
| Participants | Dysport |
|---|---|
| Reinjection cycle visit — Yes | 52 |
| Reinjection cycle visit — No | 6 |
| Reinjection cycle visit — No opinion | 12 |
| Reinjection cycle visit — Missing | 0 |
| Last study visit — Yes | 42 |
| Last study visit — No | 14 |
| Last study visit — No opinion | 12 |
| Last study visit — Missing | 6 |
Participants were asked to complete EQ-5D-5L questionnaire to assess their current health status. The EQ-5D-5L was a generic, preference-based measure of health-related quality of life (QoL). Questions were answered based on how the participant was feeling "Today". The EQ-5D-5L consists of 2 parts: EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system included questions for each of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS recorded participant's self-rated health on a vertical 20-centimeter VAS where the endpoints were labelled "The best health you can imagine" and "The worst health you can imagine". The EQ-5D-5L questionnaire scores range from 0-100, where 0= worst self-perceived health and 100= best self-perceived health. Positive change from baseline indicates an improvement in QoL.
| units on a scale | Dysport |
|---|---|
| Mobility: Last study visit | -0.3 ± 0.8 |
| Self-care: Last study visit | -0.0 ± 0.8 |
| Usual activities: Last study visit | -0.3 ± 1.0 |
| Pain/discomfort: Last study visit | -0.3 ± 0.9 |
| Anxiety/depression: Last study visit | -0.1 ± 0.9 |
| EQ VAS: Last study visit | 4.27 ± 18.71 |
The SF-12 was a short form questionnaire survey consisting of 12 questions, which were a subset of the SF-36 health survey. Most of the questions were answered based on how the participant had felt over the previous 4 weeks. The SF-12 covers 8 domains, including physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional and mental health. The SF-12 questionnaire survey scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Positive change from baseline indicates an improvement in QoL.
| units on a scale | Dysport |
|---|---|
| Physical score: Last study visit | 3.985 ± 7.358 |
| Mental score: Last study visit | -0.008 ± 9.631 |
Collected over From first injection of study treatment up to end of the study or early withdrawal, approximately 40 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dysport | 1/157 (0.6%) | 19/157 (12.1%) | 72/157 (45.9%) |
| Event | Dysport |
|---|---|
| EpilepsyNervous system disorders | 2/157 |
| Myocardial infarctionCardiac disorders | 2/157 |
| PneumoniaInfections and infestations | 2/157 |
| Brain stem strokeNervous system disorders | 1/157 |
| DysarthriaNervous system disorders | 1/157 |
| Ischaemic strokeNervous system disorders | 1/157 |
| Myasthenic syndromeNervous system disorders | 1/157 |
| Vith nerve paralysisNervous system disorders | 1/157 |
| Ventricular extrasystolesCardiac disorders | 1/157 |
| Intervertebral discitisInfections and infestations | 1/157 |
| Event | Dysport |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 11/157 |
| FallInjury, poisoning and procedural complications | 10/157 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 5/157 |
| FatigueGeneral disorders | 5/157 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 4/157 |
| DizzinessNervous system disorders | 4/157 |
| ContusionInjury, poisoning and procedural complications | 4/157 |
| DepressionPsychiatric disorders | 4/157 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 3/157 |
| BronchitisInfections and infestations | 3/157 |
The ITT population included all participants who were injected at least once with the study treatment, who received at least one day of GSC therapy during the study and for whom a primary TT limb had been defined.
| Age, Categorical(Participants) | Dysport |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 122 |
| >=65 years | 31 |
| Age, Continuous(years) | Dysport |
|---|---|
| Mean | 52.9 ± 12.6 |
| Sex: Female, Male(Participants) | Dysport |
|---|---|
| Female | 53 |
| Male | 100 |
| Race/Ethnicity, Customized(Participants) | Dysport |
|---|---|
| Race: White | 126 |
| Race: Black or African American | 7 |
| Race: Asian | 2 |
| Race: Missing | 18 |
| Ethnicity: Not Hispanic/Latino | 135 |
| Ethnicity: Missing | 18 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Access criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Data sharing details ↗ · vivli.org
The record gives a start of Dec 2016, a primary completion of Apr 2018 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2019, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A