Trial · NCT01893411
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
NCT01893411, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2017-05-12
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 Leg(s) in Cerebral Palsy. Trials, record NCT01893411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01893411
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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 Leg(s) in Cerebral Palsy
- NCT number
- NCT01893411
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 311 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Lower Limb Spasticity Due to Cerebral Palsy
- Interventions
- IncobotulinumtoxinA (16 Units per kg body weight), IncobotulinumtoxinA (12 Units per kg body weight), IncobotulinumtoxinA (4 Units per kg body weight)
- First posted
- 2013-07-09
- Last updated
- 2021-08-05
- Other registries' IDs
- eudract:2012-005054-30
- Results first posted
- 2017-05-12
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) | Baseline, Week 4 | 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 primary efficacy analysis i.e. "primary body side" was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study. Values represent least square (LS) mean differences between baseline and Week 4 resulting from MMRM (Mixed Model Repeated Measurement) 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: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle | Baseline, Week 4 | This variable is classified as co-primary to satisfy a Food and Drug Administration (FDA) request. The GICS-PF scale is a 7-Point Likert Scale for the assessment of the functional change due to treatment of plantar flexor spasticity only. Ranges from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. "primary body side" was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study. Values represent least square (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 | Change From Baseline in the AS Score of Plantar Flexors of the Nonprimary Body Side in Participants With Bilateral Treatment at Day 29 (Week 4) of the First (1st) and Second Injection Cycle (2nd IC) | Baseline, Week 4 of 1st IC and Week 16-40 of 2nd IC | 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). Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) 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 | Change From Baseline in the AS Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the Second Injection Cycle | Baseline to Week 4 of 2nd IC (Week 16-40) | 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 primary efficacy analysis i.e. "primary body side" was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study. Values represent least square (LS) mean differences between baseline and Week 16-40 resulting from MMRM (Mixed Model Repeated Measurement) 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 | Changes From Baseline in AS Score of Plantar Flexors of the Primary Body Side at Day 57 (Week 8) and Day 85 (Week 12) of the First and of the Second Injection Cycle | Baseline to Week 8 and 12 of 1st IC and 2nd IC (Week 20-44 and 24-48) | 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 primary efficacy analysis i.e. "primary body side" was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study. Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) 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 | Changes From Baseline in AS Score of Knee Flexors or Thigh Adductors in Participants With Unilateral Treatment at Day 29 (Week 4) of the First and of the Second Injection Cycle | Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40) | 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). Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) 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. KF = Knee Flexors; TA = Thigh Adductors; w = week. |
| Secondary | Changes From Baseline in Modified Tardieu Scale [MTS] of Plantar Flexors of Primary Body Side at Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12) of the First and of the Second Injection Cycle | Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48) | The Modified Tardieu Scale (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, i.e. the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, i.e. improvement of dynamic muscle spasticity. Values represent least square (LS) mean differences between baseline and the respective week (w) 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 model used for comparison and are therefore provided separately for each comparison. |
| Secondary | Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale [GICS] at Day 29 (Week 4) of the First and Second Injection Cycle | Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40) | The Global Impression of Change Scales (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 are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function). Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) 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 | Investigator's Global Impression of Change of GICS-Plantar-Flexor of Primary Body Side at Day 29 (Week 4) of the First and Second Injection Cycle | Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40) | 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 are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. "primary body side" was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study. Values represent least square (LS) mean differences between baseline and the respective week (w) 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 | Changes From Baseline in Gross Motor Function Measure [GMFM]-66 Score at the End of First Injection Cycle and at the End of Study Visit | Baseline to Week 12-36 of 1st IC and 2nd IC (End of study = Week 24-72) | 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). Values represent least square (LS) mean differences between baseline and the respective week (w) 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) | Baseline, Week 4 | FAS population is subset in the SES for whom primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) \[participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the 1st IC) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle | Baseline, Week 4 | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the AS Score of Plantar Flexors of the Nonprimary Body Side in Participants With Bilateral Treatment at Day 29 (Week 4) of the First (1st) and Second Injection Cycle (2nd IC) | Baseline, Week 4 of 1st IC and Week 16-40 of 2nd IC | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the AS Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the Second Injection Cycle | Baseline to Week 4 of 2nd IC (Week 16-40) | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in AS Score of Plantar Flexors of the Primary Body Side at Day 57 (Week 8) and Day 85 (Week 12) of the First and of the Second Injection Cycle | Baseline to Week 8 and 12 of 1st IC and 2nd IC (Week 20-44 and 24-48) | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in AS Score of Knee Flexors or Thigh Adductors in Participants With Unilateral Treatment at Day 29 (Week 4) of the First and of the Second Injection Cycle | Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40) | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Modified Tardieu Scale [MTS] of Plantar Flexors of Primary Body Side at Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12) of the First and of the Second Injection Cycle | Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48) | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Angle | LEAST_SQUARES_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 the First and Second Injection Cycle | Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40) | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Investigator's Global Impression of Change of GICS-Plantar-Flexor of Primary Body Side at Day 29 (Week 4) of the First and Second Injection Cycle | Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40) | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Gross Motor Function Measure [GMFM]-66 Score at the End of First Injection Cycle and at the End of Study Visit | Baseline to Week 12-36 of 1st IC and 2nd IC (End of study = Week 24-72) | FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline \[Day 1\] or the investigator's GICS-PF \[for participants with bilateral treatment on same body side\] at Day 29 \[Week 4\] of the first injection cycle) were available. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group296
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | Week 4 of 1st IC (high versus low) | -0.7 | Standard Error 0.061 | Units on a scale |
| Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | Week 4 of 1st IC (high versus low) | -0.66 | Standard Error 0.084 | Units on a scale |
| Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | Week 4 of 1st IC (mid versus low) | -0.7 | Standard Error 0.089 | Units on a scale |
| Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | Week 4 of 1st IC (mid versus low) | -0.66 | Standard Error 0.088 | Units on a scale |
| Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | Week 4 of 1st IC (high versus low) | 1.53 | Standard Error 0.059 | Units on a scale |
| Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | Week 4 of 1st IC (high versus low) | 1.37 | Standard Error 0.081 | Units on a scale |
| Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | Week 4 of 1st IC (mid versus low) | 1.38 | Standard Error 0.092 | Units on a scale |
| Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | Week 4 of 1st IC (mid versus low) | 1.32 | Standard Error 0.09 | Units on a scale |
| Change From Baseline in the AS Score of Plantar Flexors of the Nonprimary Body Side in Participants With Bilateral Treatment at Day 29 (Week 4) of the First (1st) and Second Injection Cycle (2nd IC) | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | Week 4 of 1st IC (high versus low) | -0.76 | Standard Error 0.073 | Units on a scale |
| Change From Baseline in the AS Score of Plantar Flexors of the Nonprimary Body Side in Participants With Bilateral Treatment at Day 29 (Week 4) of the First (1st) and Second Injection Cycle (2nd IC) | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | Week 4 of 1st IC (high versus low) | -0.61 | Standard Error 0.104 | Units on a scale |
1 to 10 of 296Source ClinicalTrials.gov
See all 296 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 156 | |
| Overall Study | STARTED | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 77 | |
| Overall Study | STARTED | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 78 | |
| Overall Study | COMPLETED | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 139 | |
| Overall Study | COMPLETED | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 70 | |
| Overall Study | COMPLETED | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 69 | |
| Overall Study | NOT COMPLETED | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 17 | |
| Overall Study | NOT COMPLETED | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 7 | |
| Overall Study | NOT COMPLETED | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 9 |
Source ClinicalTrials.gov
Adverse events84
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 | Cough | Respiratory, thoracic and mediastinal disorders | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 3 | 156 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 1 | 77 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 4 | 78 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 17 | 156 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 8 | 77 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 9 | 78 | |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 3 | 156 | |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 1 | 77 | |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 7 | 78 | |
| serious | Brain contusion | Injury, poisoning and procedural complications | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 0 | 156 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | ||
| Total, all-cause mortality | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | ||
| Total, all-cause mortality | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | ||
| Total, other adverse events | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 23 | 156 |
| Total, other adverse events | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 10 | 77 |
| Total, other adverse events | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 15 | 78 |
| Total, serious adverse events | High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin) | 7 | 156 |
| Total, serious adverse events | Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 1 | 77 |
| Total, serious adverse events | Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin) | 6 | 78 |
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/NCT01893411
GET https://conductscience.org/api/trials/v1/NCT01893411/results?page=2