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NCT02969356 · ClinicalTrials.gov registry record · Phase 4

Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)

A Phase 4 study, sponsored by Ipsen.

Completed
Registry status
Phase 4
Development phase
157
Enrollment target

NCT02969356: Completed Phase 4 study, sponsored by Ipsen.

NCT02969356 is a Phase 4 study that has completed, run by Ipsen. The registered enrollment target is 157 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02969356, a Phase 4 study, has completed, sponsored by Ipsen.

COMPLETED
Registry status
Phase 4
Development phase
157 participants
Enrollment target

Study Summary

The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.

Primary Outcome

Percentage of responder participants according to AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (

Interventions

  • BIOLOGICAL Botulinum toxin type A
  • OTHER GSC

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2016-12-18
Est. Completion 2018-07
Phase Phase 4
Ipsen

85 total trials

What the finished NCT02969356 record still lists

NCT02969356 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Botulinum toxin type A is the first listed.

NCT02969356 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02969356 about?

NCT02969356 is a clinical study titled "Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)". The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.

What is the current status of trial NCT02969356?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 157 participants. The study started on 2016-12-18. Estimated completion is 2018-07.

What interventions are being tested in trial NCT02969356?

The interventions under investigation include: Botulinum toxin type A (BIOLOGICAL), GSC (OTHER).

Who is sponsoring clinical trial NCT02969356?

This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02969356's enrollment target sits among peer trials

157 519th of 2000 higher than 1,480 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT02969356, the US trial registry maintained by the National Library of Medicine. NCT02969356 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.