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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00607542 |
Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although for adults there is dosing,safety and efficacy information in the package insert, this is not the case for children. The purpose of this study is to determine how fast the drug is cleared from the body, the correct dose, and long-term safety and efficacy for children with spasticity.
Condition | Intervention | Phase |
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Spasticity Cerebral Palsy |
Drug: baclofen |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Pediatric Pharmacokinetic and Pharmacodynamic Study of Oral Baclofen for the Treatment of Spasticity Associated With Cerebral Palsy |
Estimated Enrollment: | 85 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
starting dose of baclofen 2.5 mg PO TID with dose escalation as tolerated
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Drug: baclofen
2.5 mg oral baclofen liquid given three times a day; dose gradually escalated as specified in the protocol
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Although oral baclofen has been used for several decades for the treatment of spasticity in adults and in children, there is very little data regarding the pharmacokinetic (PK) or pharmacodynamic (PD) properties of baclofen in children. Therefore, pediatric guidelines, including dose ranges, dosing schedules, dose escalation strategies and anticipated side effects are extrapolated from adult data and require an assumption that safety and efficacy in children is comparable to that in adults. Furthermore, there is wide variability in dosing strategies among practitioners who treat children with cerebral palsy (CP) with respect to starting doses, maximum doses and rates of dose escalation.Establishment of safe and effective dosing strategies for children with CP requires an understanding of the PK and PD properties of baclofen in children and recognition of individual differences that may contribute to divergent clinical responses to baclofen among children with CP.
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Gross Motor Function Classification Scale (GMFCS) Level II - V
*GMFCS classifies children by functional mobility with Level I indicating minimal motor disability and V indicating total body involvement and dependence on others for mobility (Palisano et al, 1997)
Exclusion Criteria:
Contact: Janice Brunstrom, MD | 314-454-2312 | brunstrom@wustl.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Richard Stevenson, MD 434-982-8184 |
Principal Investigator: | Janice Brunstrom, MD | Washington University of St. Louis |
Principal Investigator: | Richard Stevenson, MD | University of Virginia |
Responsible Party: | Washington University of St. Louis ( Janice Brunstrom, MD ) |
Study ID Numbers: | 267200603421, 267200603421 |
Study First Received: | January 22, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00607542 |
Health Authority: | United States: Food and Drug Administration |
spasticity cerebral palsy baclofen pharmacokinetics |
pharmacodynamics dosing safety efficacy |
Brain Damage, Chronic Baclofen Central Nervous System Diseases Brain Diseases Paralysis Signs and Symptoms Muscle Spasticity |
Cerebral Palsy Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations Brain Injuries |
Neuromuscular Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Neuromuscular Agents Pharmacologic Actions |
Muscle Relaxants, Central Therapeutic Uses GABA Agonists GABA Agents Peripheral Nervous System Agents Central Nervous System Agents |