Trial · NCT01603641
BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
NCT01603641, Phase 3, Completed, Allergan; results first posted 2019-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity. Trials, record NCT01603641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01603641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
- NCT number
- NCT01603641
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 370 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Pediatrics, Muscle Spasticity, Cerebral Palsy
- Interventions
- Botulinum Toxin Type A
- First posted
- 2012-05-22
- Last updated
- 2019-08-21
- Other registries' IDs
- eudract:2012-000084-24
- Results first posted
- 2019-08-21
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks) | Safety population included all treated participants. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | BOTOX® | 65.4 | percentage of participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BOTOX® | 370 | |
| Overall Study | Safety Population (Treated) | BOTOX® | 367 | |
| Overall Study | Modified Intent-to-treat Population | BOTOX® | 366 | |
| Overall Study | COMPLETED | BOTOX® | 335 | |
| Overall Study | NOT COMPLETED | BOTOX® | 35 |
Source ClinicalTrials.gov
Adverse events21
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 | Pyrexia | General disorders | BOTOX® | 27 | 367 | |
| other | Upper respiratory tract infection | Infections and infestations | BOTOX® | 67 | 367 | |
| other | Nasopharyngitis | Infections and infestations | BOTOX® | 65 | 367 | |
| other | Bronchitis | Infections and infestations | BOTOX® | 21 | 367 | |
| serious | Arrhythmia | Cardiac disorders | BOTOX® | 1 | 367 | |
| serious | Entropion | Eye disorders | BOTOX® | 1 | 367 | |
| serious | Strabismus | Eye disorders | BOTOX® | 1 | 367 | |
| serious | Cataract | Eye disorders | BOTOX® | 1 | 367 | |
| serious | Pharyngitis | Infections and infestations | BOTOX® | 4 | 367 | |
| serious | Pneumonia | Infections and infestations | BOTOX® | 4 | 367 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BOTOX® | 0 | 367 |
| Total, other adverse events | BOTOX® | 145 | 367 |
| Total, serious adverse events | BOTOX® | 24 | 367 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01603641
GET https://conductscience.org/api/trials/v1/NCT01603641/events?page=2