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

NCT01520545 | Completed Phase 3

• 1 other identifier: CNS-GAB101US
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Severe Spasticity

Keywords

Gablofen; baclofen injection

Outcome Measures

Primary Outcomes (1)

• The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.

  The rate of inflammatory granulomas in patients given 3 mg/mL Gablofen® (baclofen injection) 3mg/mL by the intrathecal route of administration.

  36-months

Secondary Outcomes (1)

• Overall safety of 3 mg/mL Gablofen® (baclofen injection) given by the intrathecal route of administration

  36-months

Study Arms (1)

Gablofen 3 mg/mL (baclofen Injection)

EXPERIMENTAL

3 mg/mL Gablofen (baclofen Injection)

Drug: Gablofen® 3 mg/mL (baclofen injection); Device: SynchroMed® II Programmable Pump

Interventions

Gablofen® 3 mg/mL (baclofen injection) DRUG

This is a prospective twelve-month Phase IIIb clinical safety trial followed by a 2-year, Phase IV study that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. Patients will be followed for the duration of their treatment with Gablofen® (baclofen injection) 3 mg/mL using the SynchroMed® II Programmable Pump or until the study is terminated.

Also known as: baclofen injection

Gablofen 3 mg/mL (baclofen Injection)

SynchroMed® II Programmable Pump DEVICE

Intrathecal programmable pump

Gablofen 3 mg/mL (baclofen Injection)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Subjects must be clinically diagnosed with sever spasticity and be receiving intrathecal baclofen
• Subjects must have a SynchroMed® II Pump already implanted
• Current treatment with intrathecal baclofen should be at the 2 mg/mL concentration
• Life expectancy greater than or equal to 12 months
• Signed written informed consent
• Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures

You may not qualify if:

• History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which is allowed
• History of any allergic reaction to baclofen
• History of inflammatory granulomas with an intrathecal infusion pump
• Any previous history of neuroleptic malignant syndrome or malignant hyperthermia
• As a result of medical review and physical examination, the Investigator considers the subject unfit for the study

Sponsors & Collaborators

• Piramal Critical Care, Ltd.: lead

Study Sites (13)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Rehabilitation Medicine Department, University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Wayne State University, School of Medicine

Dearborn, Michigan, 48124, United States

Location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Vanderbilt University Medical Center, Department of Pediatrics

Nashville, Tennessee, 37232, United States

Location

Cook Children's Health Care System

Fort Worth, Texas, 76104, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

University of Utah, Division of PM&R

Salt Lake City, Utah, 84132, United States

Location

The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Gerard Francisco, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 30, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)