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NCT03469999 · ClinicalTrials.gov registry record · Phase 3
Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
A Phase 3 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT03469999: Completed Phase 3 study, sponsored by Columbia University.
NCT03469999 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03469999, a Phase 3 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.
Primary Outcome
Energy expenditure (oxygen consumption (VO2)) will be measured during the 6 minute walk test using a portable metabolic cart. The participants will use a 10 meter walkway to walk back and forth during the 6 minutes to coverage as much distance as possible. During this time they will be wearing a portable spirometric device that collects the oxygen consumption (VO2) per minute.
Interventions
- DRUG Dysport Injectable Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2021-05-26 |
| Phase | Phase 3 |
What the finished NCT03469999 record still lists
NCT03469999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Dysport Injectable Product is the first listed.
NCT03469999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03469999 about?
NCT03469999 is a clinical study titled "Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy". This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.
What is the current status of trial NCT03469999?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2018-12-12. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT03469999?
The interventions under investigation include: Dysport Injectable Product (DRUG).
Who is sponsoring clinical trial NCT03469999?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03469999's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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