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NCT02106351 · ClinicalTrials.gov registry record · Phase 3
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
NCT02106351: Completed Phase 3 study, sponsored by Ipsen.
NCT02106351 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 212 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02106351, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).
Primary Outcome
The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable incr
Interventions
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2014-04 |
| Est. Completion | 2018-09-04 |
| Phase | Phase 3 |
What the finished NCT02106351 record still lists
NCT02106351 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum toxin type A is the first listed.
NCT02106351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02106351 about?
NCT02106351 is a clinical study titled "Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children". The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).
What is the current status of trial NCT02106351?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2014-04. Estimated completion is 2018-09-04.
What interventions are being tested in trial NCT02106351?
The interventions under investigation include: Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT02106351?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02106351's enrollment target sits among peer trials
212 1335th of 2000 higher than 664 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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