Trial · NCT02106351
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
NCT02106351, Phase 3, Completed, Ipsen; results first posted 2019-12-24
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ConductScience Library. Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children. Trials, record NCT02106351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02106351
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
- NCT number
- NCT02106351
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 212 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children
- Interventions
- Botulinum toxin type A
- First posted
- 2014-04-08
- Last updated
- 2022-09-28
- Other registries' IDs
- eudract:2010-021817-22
- Results first posted
- 2019-12-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG | Baseline (TC 1, Day 1) and TC 1, Week 6. | The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. |
| Secondary | Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6 | TC 1, Week 6. | The PGA of treatment response was assessed by asking the investigator the following question: 'How would you rate the response to treatment in the subject's upper limb since the start of the study?'. Answers were on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). The mean scores for each treatment group at TC 1, Week 6 are presented. |
| Secondary | Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6 | TC 1, Week 6. | The GAS is a functional 5-point scale used to measure progress towards individual therapy goals. At start of each TC, 1 to 3 individual goals were defined for each subject by investigator and child's parents/guardians/caregivers prior to treatment. Outcome to reach each goal was rated on a 5-point scale ranging from -2 to +2 (-2: much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, +1: somewhat more than expected outcome, +2: much more than expected outcome). Higher score indicates a better outcome. A GAS T-score was calculated as: 50+(10∑\_(i=1)\^n wi xi)/√(0.7∑\_(i=1)\^n wi\^2 +0.3(∑\_(i=1)\^n wi)\^2) where, xi = rating of ith goal post-baseline; wi = weight of ith goal, calculated as importance \* difficulty as defined at baseline; n = number of goals assessed at baseline and post-baseline. A GAS T-score of 50 indicates goals achieved as expected. Scores below 50 reflect under attainment of goals and scores above 50 reflect over attainment of goals. |
| Other | Mean Change From Baseline to TC 1 Week 16 in MAS Score in the TC 1 PTMG | Baseline (TC 1, Day 1) and TC 1, Week 16. | The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. |
| Other | Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Elbow Flexors of the Study Limb | Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16. | The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the elbow flexors. |
| Other | Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Wrist Flexors of the Study Limb | Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16. | The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the wrist flexors. |
| Other | Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Finger Flexors of the Study Limb | Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16. | The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the finger flexors. |
| Other | Mean PGA Score at TC 1 Week 16 | Baseline (TC 1, Day 1) and TC 1, Week 16. | The PGA of treatment response was assessed by asking the investigator the following question: 'How would you rate the response to treatment in the subject's upper limb since the start of the study?'. Answers were on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). The mean scores for each treatment group at TC 1 Week 16 are presented. |
| Other | Mean GAS Total Score at TC 1, Week 16 | Baseline (TC 1, Day 1) and TC 1, Week 16. | The GAS is a functional 5-point scale used to measure progress towards individual therapy goals. At start of each TC, 1 to 3 individual goals were defined for each subject by investigator and child's parents/guardians/caregivers prior to treatment. Outcome to reach each goal was rated on a 5-point scale ranging from -2 to +2 (-2: much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, +1: somewhat more than expected outcome, +2: much more than expected outcome). Higher score indicates a better outcome. A GAS T-score was calculated as: 50+(10∑\_(i=1)\^n wi xi)/√(0.7∑\_(i=1)\^n wi\^2 +0.3(∑\_(i=1)\^n wi)\^2) where, xi = rating of ith goal post-baseline; wi = weight of ith goal, calculated as importance \* difficulty as defined at baseline; n = number of goals assessed at baseline and post-baseline. A GAS T-score of 50 indicates goals achieved as expected. Scores below 50 reflect under attainment of goals and scores above 50 reflect over attainment of goals. |
| Other | Mean Change From Baseline to TC 1, Week 16 in the Paediatric Quality of Life (PedsQL) Scores | Baseline (TC 1, Day 1) and TC 1, Week 16. | Parents/guardians completed questionnaires on their child's quality of life. The PedsQL parent inventory measured healthcare concepts for children/adolescents aged 2-18 years. The Generic Core Scales include physical, emotional, social and school aspects. The CP module was also completed. Scores were transformed on a scale from 0 to 100 with higher scores indicating a better quality of life. Mean changes from baseline to TC 1, Week 16 are presented for the General Core Scale and for the CP module. A positive change from baseline indicates an improvement in quality of life. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG | Baseline (TC 1, Day 1) and TC 1, Week 6. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. | score on a scale | MEAN |
| SECONDARY | Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6 | TC 1, Week 6. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available are presented. | score on a scale | MEAN |
| SECONDARY | Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6 | TC 1, Week 6. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available are presented. | T-score | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to TC 1 Week 16 in MAS Score in the TC 1 PTMG | Baseline (TC 1, Day 1) and TC 1, Week 16. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at the timepoint analysed are presented. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Elbow Flexors of the Study Limb | Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the elbow flexors are presented. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Wrist Flexors of the Study Limb | Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the wrist flexors are presented. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Finger Flexors of the Study Limb | Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the finger flexors are presented. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Mean PGA Score at TC 1 Week 16 | Baseline (TC 1, Day 1) and TC 1, Week 16. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with available data at the timepoint analysed are presented. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Mean GAS Total Score at TC 1, Week 16 | Baseline (TC 1, Day 1) and TC 1, Week 16. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with available data at the timepoint analysed are presented. | T-score | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline to TC 1, Week 16 in the Paediatric Quality of Life (PedsQL) Scores | Baseline (TC 1, Day 1) and TC 1, Week 16. | The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects who were assessed at each timepoint are presented. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG | Dysport 2 U/kg | -1.5 | Standard Deviation 1.1 | score on a scale | |
| Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG | Dysport 8 U/kg | -1.9 | Standard Deviation 1.0 | score on a scale | |
| Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG | Dysport 16 U/kg | -2.2 | Standard Deviation 0.9 | score on a scale | |
| Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6 | Dysport 2 U/kg | 1.7 | Standard Deviation 0.9 | score on a scale | |
| Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6 | Dysport 8 U/kg | 2.0 | Standard Deviation 0.9 | score on a scale | |
| Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6 | Dysport 16 U/kg | 2.0 | Standard Deviation 0.9 | score on a scale | |
| Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6 | Dysport 2 U/kg | 51.3 | Standard Deviation 9.9 | T-score | |
| Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6 | Dysport 8 U/kg | 52.6 | Standard Deviation 10.1 | T-score | |
| Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6 | Dysport 16 U/kg | 52.0 | Standard Deviation 9.6 | T-score | |
| Mean Change From Baseline to TC 1 Week 16 in MAS Score in the TC 1 PTMG | Dysport 2 U/kg | -1.0 | Standard Deviation 1.0 | score on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Cycle 1 | STARTED | Dysport 2 U/kg | 71 | |
| Treatment Cycle 1 | STARTED | Dysport 8 U/kg | 70 | |
| Treatment Cycle 1 | STARTED | Dysport 16 U/kg | 71 | |
| Treatment Cycle 1 | Received Treatment in TC 1 | Dysport 2 U/kg | 70 | |
| Treatment Cycle 1 | Received Treatment in TC 1 | Dysport 8 U/kg | 70 | |
| Treatment Cycle 1 | Received Treatment in TC 1 | Dysport 16 U/kg | 70 | |
| Treatment Cycle 1 | COMPLETED | Dysport 2 U/kg | 66 | |
| Treatment Cycle 1 | COMPLETED | Dysport 8 U/kg | 67 | |
| Treatment Cycle 1 | COMPLETED | Dysport 16 U/kg | 67 | |
| Treatment Cycle 1 | NOT COMPLETED | Dysport 2 U/kg | 5 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events603
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Viral upper respiratory tract infection | Infections and infestations | TC1: Dysport 2 U/kg | 10 | 70 | 13 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 1: Dysport 8 U/kg | 6 | 70 | 7 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 1: Dysport 16 U/kg | 6 | 70 | 7 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 2: Dysport 8 U/kg | 7 | 88 | 8 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 2: Dysport 16 U/kg | 6 | 90 | 6 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 3: Dysport 8 U/kg | 6 | 49 | 9 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 3: Dysport 16 U/kg | 5 | 58 | 8 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 4: Dysport 8 U/kg | 0 | 22 | 0 |
| other | Viral upper respiratory tract infection | Infections and infestations | TC 4: Dysport 16 U/kg | 3 | 33 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | TC1: Dysport 2 U/kg | 5 | 70 | 6 |
1 to 10 of 603Source ClinicalTrials.gov
See all 603 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TC1: Dysport 2 U/kg | 0 | 70 |
| Total, all-cause mortality | TC 1: Dysport 8 U/kg | 0 | 70 |
| Total, all-cause mortality | TC 1: Dysport 16 U/kg | 0 | 70 |
| Total, all-cause mortality | TC 2: Dysport 8 U/kg | 0 | 88 |
| Total, all-cause mortality | TC 2: Dysport 16 U/kg | 0 | 90 |
| Total, all-cause mortality | TC 3: Dysport 8 U/kg | 0 | 49 |
| Total, all-cause mortality | TC 3: Dysport 16 U/kg | 0 | 58 |
| Total, all-cause mortality | TC 4: Dysport 8 U/kg | 0 | 22 |
| Total, all-cause mortality | TC 4: Dysport 16 U/kg | 0 | 33 |
| Total, other adverse events | TC1: Dysport 2 U/kg | 15 | 70 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02106351
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