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NCT01249417 · ClinicalTrials.gov registry record · Phase 3

Dysport® Pediatric Lower Limb Spasticity Study

A Phase 3 study, sponsored by Ipsen.

Completed
Registry status
Phase 3
Development phase
241
Enrollment target

NCT01249417 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 241 participants.

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The verdict

NCT01249417, a Phase 3 study, has completed, sponsored by Ipsen.

COMPLETED
Registry status
Phase 3
Development phase
241 participants
Enrollment target

Study Summary

The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Interventions

  • DRUG Placebo
  • BIOLOGICAL Botulinum toxin type A

Trial Details

FieldValue
Enrollment Target 241 participants
Start Date 2011-07
Est. Completion 2014-06
Phase Phase 3

Sponsor

Ipsen

85 total trials

What the Registry Record Tells You About NCT01249417

The ClinicalTrials.gov registry entry for NCT01249417 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01249417 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01249417 about?

NCT01249417 is a clinical study titled "Dysport® Pediatric Lower Limb Spasticity Study". The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain cause...

What is the current status of trial NCT01249417?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2011-07. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01249417?

The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).

Who is sponsoring clinical trial NCT01249417?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.