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

Completed · Phase 3

Conditions studied: Severe Spasticity

In brief

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

Key facts

Study ID

NCT01520545

Run by

Piramal Critical Care, Ltd.

People needed

153

Starts

2012-12-01

Expected to finish

2016-10-01

Last updated by the study team

2019-05-03

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 4 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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Loma Linda University — Loma Linda, California, United States
• Rehabilitation Medicine Department, University of Miami, Miller School of Medicine — Miami, Florida, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Wayne State University, School of Medicine — Dearborn, Michigan, United States
• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Vanderbilt University Medical Center, Department of Pediatrics — Nashville, Tennessee, United States
• Cook Children's Health Care System — Fort Worth, Texas, United States
• TIRR Memorial Hermann — Houston, Texas, United States
• University of Utah, Division of PM&R — Salt Lake City, Utah, United States
• The Medical College of Wisconsin Department of Physical Medicine and Rehabilitation — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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