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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by (Responsible Party): | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00607542 |
Purpose
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 |
|---|---|---|
|
Spasticity Cerebral Palsy |
Drug: baclofen |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pediatric Pharmacokinetic and Pharmacodynamic Study of Oral Baclofen for the Treatment of Spasticity Associated With Cerebral Palsy |
| Enrollment: | 61 |
| Study Start Date: | November 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
starting dose of baclofen 2.5 mg PO TID with dose escalation as tolerated
|
Drug: baclofen
2.5 mg oral baclofen tablets given three times a day; dose gradually escalated as specified in the protocol
Other Name: Lioresal
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Rehabilitation Institute of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| United States, Louisiana | |
| Children's Hospital of Lousiana | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, Maryland | |
| Kennedy Krieger Institute | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Minnesota | |
| Gillette Children's Speciality Healthcare | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, Missouri | |
| Children's Mercy Hospital and Clinics | |
| Kansas City, Missouri, United States, 64108 | |
| Washington Univeristy - St. Louis Children's hospital | |
| St. Louis, Missouri, United States, 63110-1093 | |
| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Texas | |
| Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Kluge Children's Rehabilitation Center - University of Virginia | |
| Charlottesville, Virginia, United States, 22903 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| Principal Investigator: | Janice Brunstrom, MD | Washington University of St. Louis |
| Principal Investigator: | Richard Stevenson, MD | University of Virginia |
More Information
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00607542 History of Changes |
| Other Study ID Numbers: | NICHD-2005-13-2, 267200603421 |
| Study First Received: | January 22, 2008 |
| Last Updated: | December 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
spasticity cerebral palsy baclofen pharmacokinetics |
pharmacodynamics dosing safety efficacy |
|
Cerebral Palsy Muscle Spasticity Paralysis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms |
Baclofen GABA-B Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |