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NCT01603628 · ClinicalTrials.gov registry record · Phase 3

BOTOX® Treatment in Pediatric Lower Limb Spasticity

A Phase 3 study, sponsored by Allergan.

Completed
Registry status
Phase 3
Development phase
384
Enrollment target

NCT01603628 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 384 participants.

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The verdict

NCT01603628, a Phase 3 study, has completed, sponsored by Allergan.

COMPLETED
Registry status
Phase 3
Development phase
384 participants
Enrollment target

Study Summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

Interventions

  • DRUG Normal Saline (Placebo)
  • BIOLOGICAL botulinum toxin Type A

Trial Details

FieldValue
Enrollment Target 384 participants
Start Date 2012-09-11
Est. Completion 2017-06-28
Phase Phase 3

Sponsor

Allergan

314 total trials

What the Registry Record Tells You About NCT01603628

The ClinicalTrials.gov registry entry for NCT01603628 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.

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

NCT01603628 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01603628 about?

NCT01603628 is a clinical study titled "BOTOX® Treatment in Pediatric Lower Limb Spasticity". This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

What is the current status of trial NCT01603628?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 384 participants. The study started on 2012-09-11. Estimated completion is 2017-06-28.

What interventions are being tested in trial NCT01603628?

The interventions under investigation include: Normal Saline (Placebo) (DRUG), botulinum toxin Type A (BIOLOGICAL).

Who is sponsoring clinical trial NCT01603628?

This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.

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

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.