Trial · NCT02002884
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy
NCT02002884, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2020-08-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy. Trials, record NCT02002884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02002884
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy
- NCT number
- NCT02002884
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 351 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Cerebral Palsy, Spasticity
- Interventions
- IncobotulinumtoxinA (8 Units per kg body weight), IncobotulinumtoxinA (6 Units per kg body weight), IncobotulinumtoxinA (2 Units per kg body weight)
- First posted
- 2013-12-06
- Last updated
- 2021-08-05
- Other registries' IDs
- eudract:2012-005496-14
- Results first posted
- 2020-08-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | Baseline and Week 4 | The AS categorizes severity of spasticity by judging resistance to passive movement. Spasticity was assessed by using the 5-point AS with:0 (no increase in tone); 1 (slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2 (more marked increase in tone, but limb easily flexed); 3 (considerable increase in tone -passive movements difficult); 4 (limb rigid in flexion or extension). Values represent least square (LS) mean differences between baseline and Week 4 resulting from Mixed Model Repeated Measurement (MMRM) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. |
| Primary | Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | Week 4 | The GICS was used to measure independently the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale, that ranges from +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). Values represent LS mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. |
| Secondary | MP: Change From Baseline in AS Score of the Other Treated UL Main Clinical Target Pattern at Week 4 | Baseline and Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. |
| Secondary | MP: Change From Baseline in AS Score in UL Treated Clenched Fist With Flexed Wrist at Week 4 | Baseline and Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. |
| Secondary | MP: Change From Baseline in AS Score for Each Treated Clinical Pattern of the UL at Week 4 | Baseline up to Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. |
| Secondary | MP: Change From Baseline in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) Assessed With 'Questionnaire on Pain Caused by Spasticity (QPS)' | Baseline, Weeks 4, 8, and 14 | Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with QPS. The QPS Total Score for pain intensity ranges from 0 ('No Hurt') to 10 ('Hurt Worst'). The QPS Total Score for the observed pain frequency ranges from 0 (Never) to 4 (Always). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. P/C = Parent/Caregiver. |
| Secondary | MP: Child's/Adolescent's, and Parent's/Caregiver's GICS in UL at Week 4 | Week 4 | The GICS was used to measure independently the child's/adolescent's, and parent's or caregiver's impression of change due to treatment. The response option was a common 7-point Likert scale, that ranges from: +3(very much improved); +2(much improved); +1(minimally improved); 0(no change); -1(minimally worse); -2(much worse); -3(very much worse). Values represent LS mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. |
| Secondary | Number of Participants With Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 | |
| Secondary | Number of Participants With Occurrence of TEAEs of Special Interest (TEAESIs) Overall and Per Treatment Cycle | Baseline up to Week 66 | |
| Secondary | Number of Participants With Occurrence of Serious TEAEs (TESAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | Baseline and Week 4 | The full analysis set (FAS) was the subset in the safety evaluation set (SES) of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available (that is, all participants who had at least an AS score in clinical pattern flexed elbow or flexed wrist at baseline \[Day 1\] or Investigator's GICS at Day 29 \[Week 4\]). | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in AS Score of the Other Treated UL Main Clinical Target Pattern at Week 4 | Baseline and Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in AS Score in UL Treated Clenched Fist With Flexed Wrist at Week 4 | Baseline and Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in AS Score for Each Treated Clinical Pattern of the UL at Week 4 | Baseline up to Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) Assessed With 'Questionnaire on Pain Caused by Spasticity (QPS)' | Baseline, Weeks 4, 8, and 14 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Child's/Adolescent's, and Parent's/Caregiver's GICS in UL at Week 4 | Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of TEAEs of Special Interest (TEAESIs) Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of Serious TEAEs (TESAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES were the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | MP Low Dose Group | High versus low | -0.93 | Standard Error 0.078 | Unit on a scale |
| MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | MP High Dose Group | High versus low | -1.15 | Standard Error 0.056 | Unit on a scale |
| MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | MP Low Dose Group | Mid versus low | -0.96 | Standard Error 0.082 | Unit on a scale |
| MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | MP Mid Dose Group | Mid versus low | -1.02 | Standard Error 0.082 | Unit on a scale |
| Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | MP Low Dose Group | High versus low | 1.55 | Standard Error 0.083 | Unit on a scale |
| Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | MP High Dose Group | High versus low | 1.64 | Standard Error 0.062 | Unit on a scale |
| Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | MP Low Dose Group | Mid versus low | 1.57 | Standard Error 0.089 | Unit on a scale |
| Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | MP Mid Dose Group | Mid versus low | 1.44 | Standard Error 0.092 | Unit on a scale |
| MP: Change From Baseline in AS Score of the Other Treated UL Main Clinical Target Pattern at Week 4 | MP Low Dose Group | High versus low | -1.03 | Standard Error 0.083 | Unit on a scale |
| MP: Change From Baseline in AS Score of the Other Treated UL Main Clinical Target Pattern at Week 4 | MP High Dose Group | High versus low | -1.13 | Standard Error 0.061 | Unit on a scale |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Period (MP) | STARTED | MP Low Dose Group | 87 | |
| Main Period (MP) | STARTED | MP Mid Dose Group | 88 | |
| Main Period (MP) | STARTED | MP High Dose Group | 176 | |
| Main Period (MP) | STARTED | OLEX (3 Injections) | 0 | |
| Main Period (MP) | Treated | MP Low Dose Group | 87 | |
| Main Period (MP) | Treated | MP Mid Dose Group | 87 | |
| Main Period (MP) | Treated | MP High Dose Group | 176 | |
| Main Period (MP) | Treated | OLEX (3 Injections) | 0 | |
| Main Period (MP) | COMPLETED | MP Low Dose Group | 81 | |
| Main Period (MP) | COMPLETED | MP Mid Dose Group | 82 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events124
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 | Nasopharyngitis | Infections and infestations | MP Low Dose Group | 5 | 87 | 5 |
| other | Nasopharyngitis | Infections and infestations | MP Mid Dose Group | 3 | 87 | 5 |
| other | Nasopharyngitis | Infections and infestations | MP High Dose Group | 6 | 176 | 6 |
| other | Nasopharyngitis | Infections and infestations | OLEX (3 Injections) | 18 | 331 | 22 |
| serious | Shunt malfunction | Injury, poisoning and procedural complications | MP Low Dose Group | 0 | 87 | 0 |
| serious | Shunt malfunction | Injury, poisoning and procedural complications | MP Mid Dose Group | 0 | 87 | 0 |
| serious | Shunt malfunction | Injury, poisoning and procedural complications | MP High Dose Group | 0 | 176 | 0 |
| serious | Shunt malfunction | Injury, poisoning and procedural complications | OLEX (3 Injections) | 1 | 331 | 2 |
| serious | Thermal burn | Injury, poisoning and procedural complications | MP Low Dose Group | 0 | 87 | 0 |
| serious | Thermal burn | Injury, poisoning and procedural complications | MP Mid Dose Group | 0 | 87 | 0 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MP Low Dose Group | 0 | 87 |
| Total, all-cause mortality | MP Mid Dose Group | 0 | 87 |
| Total, all-cause mortality | MP High Dose Group | 0 | 176 |
| Total, all-cause mortality | OLEX (3 Injections) | 0 | 331 |
| Total, other adverse events | MP Low Dose Group | 5 | 87 |
| Total, other adverse events | MP Mid Dose Group | 3 | 87 |
| Total, other adverse events | MP High Dose Group | 6 | 176 |
| Total, other adverse events | OLEX (3 Injections) | 18 | 331 |
| Total, serious adverse events | MP Low Dose Group | 2 | 87 |
| Total, serious adverse events | MP Mid Dose Group | 1 | 87 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT02002884
GET https://conductscience.org/api/trials/v1/NCT02002884/results?page=2