Trial · NCT01905683
Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
NCT01905683, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2017-10-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy. Trials, record NCT01905683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01905683
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
- NCT number
- NCT01905683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 370 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
- Interventions
- IncobotulinumtoxinA (16-20 Units per kg body weight)
- First posted
- 2013-07-23
- Last updated
- 2017-10-27
- Other registries' IDs
- eudract:2012-005055-17
- Results first posted
- 2017-10-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | From the timepoint of first injection up to end of study visit (Week 50-66) | TEAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected. |
| Primary | Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle | From the timepoint of first injection until end of study visit (Week 50-66) | TEAEs occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as TEAESI. Values reported here refer to the number of participants affected. |
| Primary | Occurrence of Treatment-emergent Serious Adverse Events (TESAEs) Overall and Per Injection Cycle | From the timepoint of first injection until end of study visit (Week 50-66) | TESAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected. |
| Secondary | Investigator's Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle | Day 99 (Week 14) of 1st, 2nd, 3rd and 4th injection cycle | The investigator's global assessment of tolerability was assessed on a 4-point ordinal scale where 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Results for Day 99 (Week 14) of 4th injection cycles were collected at the end of study visit. |
| Secondary | Changes in AS Score of Left and Right Plantar Flexors (PF) From Baseline to All Other Visits, From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle Only) and Day 99 (Week 14) of the Respective Injection Cycle | Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle only) and Day 99 (Week 14) of the respective Injection Cycle | The Ashworth Scale (AS) is a well-known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for efficacy analysis that is, "primary body side" was decided by investigator at screening and was kept throughout the entire study. V3 = Week 4 of 1st Injection Cycle; V4 = Week 8 of 1st Injection Cycle; V5 = Day 1 of 2nd Injection Cycle; V6= Week 4 of 2nd Injection Cycle; V7 = Day 1 of 3rd Injection Cycle; V8 = Week 4 of 3rd Injection Cycle; V9 = Day 1 of 4th Injection Cycle; V10 = Week 4 of 4th Injection Cycle; V11= Week 14th of 4th Injection Cycle = end of study visit. |
| Secondary | Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale (GICS) at Day 29 (Week 4) of Each Injection Cycle | Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle | The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function). |
| Secondary | Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of Left and Right PF at Day 29 (Week 4) of Each Injection Cycle | Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle | The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is a 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for efficacy analysis that is "primary body side" was decided by investigator at screening and was kept throughout the entire study. |
| Secondary | Changes in Modified Tardieu Scale (MTS) of Left and Right PF From Baseline to All Other Visits, From Day 1 of Each Injection Cycle (IC) to Day 29 (Week 4), Day 57 (Week 8, 1st IC Only) and Day 99 (Week 14) of the Respective Injection Cycle | Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC | The MTS assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a "catch-and-release" or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, that is, the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, that is, improvement of dynamic muscle spasticity. V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5 = Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit. |
| Secondary | Change in Scores of Pain Intensity (From Participants) and Frequency (From Parent/Caregiver) From Baseline to All Visits, From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC Cycle Only) and Day 99 (Week 14) of Respective Injection | Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC | The questionnaire on pain caused by Spasticity (QPS) is a participant-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. 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). V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5= Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit. |
| Secondary | Changes in Gross Motor Function Measure (GMFM)-66 Score From Baseline to All Injection Visits and End of Study | Baseline to Day 1 of 2nd (V5), 3rd (V7), 4th (V9) IC and End of study (Week 44-68) (V11) | The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best). |
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 | Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | From the timepoint of first injection up to end of study visit (Week 50-66) | The SES was the subset of all participants treated with IP at least once. | participants | NUMBER |
| PRIMARY | Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle | From the timepoint of first injection until end of study visit (Week 50-66) | The SES was the subset of all participants treated with IP at least once. | participants | NUMBER |
| PRIMARY | Occurrence of Treatment-emergent Serious Adverse Events (TESAEs) Overall and Per Injection Cycle | From the timepoint of first injection until end of study visit (Week 50-66) | The SES was the subset of all participants treated with IP at least once. | participants | NUMBER |
| SECONDARY | Investigator's Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle | Day 99 (Week 14) of 1st, 2nd, 3rd and 4th injection cycle | The SES was the subset of all participants treated with IP at least once. | participants | NUMBER |
| SECONDARY | Changes in AS Score of Left and Right Plantar Flexors (PF) From Baseline to All Other Visits, From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle Only) and Day 99 (Week 14) of the Respective Injection Cycle | Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle only) and Day 99 (Week 14) of the respective Injection Cycle | The full analysis set (FAS) was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. | units on a scale | MEAN |
| SECONDARY | Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale (GICS) at Day 29 (Week 4) of Each Injection Cycle | Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle | The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. | units on a scale | MEAN |
| SECONDARY | Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of Left and Right PF at Day 29 (Week 4) of Each Injection Cycle | Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle | The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. | units on a scale | MEAN |
| SECONDARY | Changes in Modified Tardieu Scale (MTS) of Left and Right PF From Baseline to All Other Visits, From Day 1 of Each Injection Cycle (IC) to Day 29 (Week 4), Day 57 (Week 8, 1st IC Only) and Day 99 (Week 14) of the Respective Injection Cycle | Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC | The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. | Degrees | MEAN |
| SECONDARY | Change in Scores of Pain Intensity (From Participants) and Frequency (From Parent/Caregiver) From Baseline to All Visits, From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC Cycle Only) and Day 99 (Week 14) of Respective Injection | Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC | The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. | units on a scale | MEAN |
| SECONDARY | Changes in Gross Motor Function Measure (GMFM)-66 Score From Baseline to All Injection Visits and End of Study | Baseline to Day 1 of 2nd (V5), 3rd (V7), 4th (V9) IC and End of study (Week 44-68) (V11) | The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. Therefore all participants from lead-in study were included in FAS. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group146
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1st Injection Cycle | 53 | participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 2nd Injection Cycle | 44 | participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 3rd Injection Cycle | 26 | participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 4th Injection Cycle | 31 | participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | Overall Period | 109 | participants | |
| Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1st Injection Cycle | 1 | participants | |
| Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 2nd Injection Cycle | 2 | participants | |
| Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 3rd Injection Cycle | 1 | participants | |
| Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 4th Injection Cycle | 0 | participants | |
| Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | Overall Period | 3 | participants |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 370 | |
| Overall Study | COMPLETED | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 319 | |
| Overall Study | NOT COMPLETED | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 51 |
Source ClinicalTrials.gov
Adverse events19
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 | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 20 | 370 | 34 |
| serious | Tenotomy | Surgical and medical procedures | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 2 | 370 | 3 |
| serious | Cast application | Surgical and medical procedures | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1 | 370 | 1 |
| serious | Arrhythmia | Cardiac disorders | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1 | 370 | 1 |
| serious | Epilepsy | Nervous system disorders | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 2 | 370 | 2 |
| serious | Clonic convulsion | Nervous system disorders | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1 | 370 | 1 |
| serious | Febrile convulsion | Nervous system disorders | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1 | 370 | 1 |
| serious | Seizure | Nervous system disorders | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1 | 370 | 4 |
| serious | Gastritis | Gastrointestinal disorders | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 1 | 370 | 1 |
| serious | Gastroenteritis | Infections and infestations | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 3 | 370 | 4 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 0 | 370 |
| Total, other adverse events | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 20 | 370 |
| Total, serious adverse events | 16 - 20 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 16 | 370 |
Source ClinicalTrials.gov
Papers2
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/NCT01905683
GET https://conductscience.org/api/trials/v1/NCT01905683/results?page=2