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Completed Phase 3 Interventional Results available

BOTOX® Treatment in Pediatric Lower Limb Spasticity

ClinicalTrials.gov ID: NCT01603628

Public ClinicalTrials.gov record NCT01603628. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 7:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study

Study identification

NCT ID
NCT01603628
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Allergan
Industry
Enrollment
384 participants

Conditions and interventions

Interventions

  • botulinum toxin Type A Biological
  • Normal Saline (Placebo) Drug

Biological · Drug

Eligibility (public fields only)

Age range
2 Years to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 10, 2012
Primary completion
Jun 27, 2017
Completion
Jun 27, 2017
Last update posted
Aug 13, 2018

2012 – 2017

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
22
Facility City State ZIP Site status
AMS Neurology Pasadena California 91106
Harrison Clinical Management Pomona California 91767
Children's Hospital Colorado Dept. of PM&R Aurora Colorado 80045
Associated Neurologists of Southern CT, P.C. Fairfield Connecticut 06824
New England Center for Clinical Research Stamford Connecticut 06905
NW FL Clinical Research Group, LLC Gulf Breeze Florida 32561
Axcess Medical Research, LLC Loxahatchee Groves Florida 33470
Pediatric Neurology, PA Orlando Florida 32819
Children's Healthcare of Atlanta Children's Rehabilitation Associates Atlanta Georgia 30342
Rehab Institute of Chicago Chicago Illinois 60611
The Children's Mercy Hospital & Clinics Kansas City Missouri 64108
Washington University School of Medicine St Louis Missouri 63110
Clinical Research Center of New Jersey Voorhees Township New Jersey 08043
NYU Hospital for Joint Diseases New York New York 10003
Columbia University Medical Center Dept. of Rehab. & Regenerative Medicine New York New York 10032
OnSite Clinical Solutions, LLC Charlotte North Carolina 28203
PMG Research of Charlotte, LLC Charlotte North Carolina 28203
Rhode Island Hospital Providence Rhode Island 02903
Vanderbilt University Medical Center Nashville Tennessee 37232
University of Texas Southwestern Medical Center Dallas Texas 75235
Baylor College of Medicine Texas Children's Hospital Houston Texas 77030
Road Runner Research San Antonio Texas 78258
Seattle Children's Hospital Seattle Washington 98105
Marshfield Clinic Marshfield Wisconsin 54449

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01603628, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2018 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01603628 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →