Oral Baclofen Study

Washington University School of Medicine is conducting a research study to determine safe and effective dosing for Oral Baclofen for children with Cerebral Palsy. This research study is being sponsored by the National Institute of Child Health and Human Development (NICHD), an agency of the federal government.

Oral Baclofen is a medication that has been used for decades to treat spasticity (muscle stiffness) in adults and children with Cerebral Palsy. However, there is currently little information about how effective Oral Baclofen is for treating spasticity in children.

Washington University School of Medicine and St. Louis Children’s Hospital are partnering with ten other sites (hospitals and universities) across the United States to conduct a study to determine the effectiveness of a liquid form of Oral Baclofen in children with Cerebral Palsy. This study will provide information regarding starting dosages, maximum dosages and rate of dosage administration. Thus providing physicians nationwide with evidence that is needed to ensure children are prescribed the safest dosage while also receiving the most beneficial effects from the medication.

To enroll, your child must have a diagnosis of Cerebral Palsy and be between the ages of 2 and 16. In addition, he or she must not have received Oral Baclofen (or Intrathecal Baclofen) 4 months prior to the start of the study. The study will require a minimum of three visits with a maximum of six visits. An overnight visit at the Pediatric Research Unit at the local Children’s Hospital may also be required for the child. Participation benefits include, but may not be limited to, medication, physical examination and diagnostic testing at no cost.

If you would like any further information or if you wish to be considered for this study, please visit this site or contact one of the sites listed below.

Washington University School of Medicine
St. Louis Children’s Hospital
St. Louis, MO
Principal Investigator: Jan Brunstrom-Hernandez, MD
Contact: Shellie Lackey
Phone: 314-454-6120
Email: lackeys@neuro.wustl.edu

Rehabilitation Institute of Chicago
Chicago, IL
Principal Investigator: Deb Gaebler-Spira, MD
Contact: Maxine M. Kuroda, PhD, MPH
Phone: 312-238-2846
Email: mkuroda@ric.org

Gillette Children’s Specialty Healthcare
St. Paul, MN
Principal Investigator: Linda Krach, MD
Phone: 651-229-3873 or 612-626-5578

University of Minnesota
Minneapolis, MN
Contact: Jennifer Engen, RN
Phone: 612-626-1421

Kluge Children’s Rehabilitation Center and Research Institute
Charlottesville, VA
Principal Investigator: Richard Stevenson, MD
Contact: Stephanie Lowenhaupt, RN, CCRC
Phone: 434-982-6421
Email: sal3q@virgina.edu

Cincinnati Children’s Hospital Medical Center
Cincinnati, OH
Principal Investigator: Jilda Vargus-Adams, MD
Contact: Lauren Kennington
Phone: 513-636-7506
Email: lauren.kennington@cchmc.org

Seattle Children’s Hospital
Seattle, WA
Principal Investigator: John McLaughlin, MD
Contact: Seattle Children’s Developmental Medicine Research
Phone: 206-884-2756