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Completed Phase 3 Interventional

Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump

ClinicalTrials.gov ID: NCT01520545

Public ClinicalTrials.gov record NCT01520545. 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 Oct 29, 2026, 2:05 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

Study to Assess the Safety of 3 mg/mL Gablofen® (Baclofen Injection) Delivered by Intrathecal Administration Using the Synchromed® II Programmable Infusion System

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Safety study to assess the 3 mg/mL baclofen injection (intrathecal) using a programmable pump

Study identification

NCT ID
NCT01520545
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Piramal Critical Care, Ltd.
Industry
Enrollment
153 participants

Conditions and interventions

Eligibility (public fields only)

Age range
4 Years and older
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
Dec 2012 (Type not available)
Primary completion
Aug 2016 (Actual)
Completion
Oct 2016 (Actual)
Last update posted
May 3, 2019

2012 – 2016

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 —
Loma Linda University Loma Linda California 92354 —
Rehabilitation Medicine Department, University of Miami, Miller School of Medicine Miami Florida 33136 —
Rehabilitation Institute of Chicago Chicago Illinois 60611 —
Wayne State University, School of Medicine Dearborn Michigan 48124 —
Gillette Children's Specialty Healthcare Saint Paul Minnesota 55101 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
The Ohio State University Columbus Ohio 43221 —
Vanderbilt University Medical Center, Department of Pediatrics Nashville Tennessee 37232 —
Cook Children's Health Care System Fort Worth Texas 76104 —
TIRR Memorial Hermann Houston Texas 77030 —
University of Utah, Division of PM&R Salt Lake City Utah 84132 —
The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation Milwaukee Wisconsin 53226 —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01520545, 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 May 3, 2019 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01520545 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →