Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
Public ClinicalTrials.gov record NCT00607542. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pediatric Pharmacokinetic and Pharmacodynamic Study of Oral Baclofen for the Treatment of Spasticity Associated With Cerebral Palsy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00607542
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- NIH
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2008
- Primary completion
- Dec 31, 2010
- Completion
- Dec 31, 2010
- Last update posted
- Dec 5, 2011
2008 – 2011
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | — |
| Children's Hospital of Lousiana | New Orleans | Louisiana | 70118 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Gillette Children's Speciality Healthcare | Saint Paul | Minnesota | 55101 | — |
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64108 | — |
| Washington Univeristy - St. Louis Children's hospital | St Louis | Missouri | 63110-1093 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Kluge Children's Rehabilitation Center - University of Virginia | Charlottesville | Virginia | 22903 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00607542, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 5, 2011 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00607542 live on ClinicalTrials.gov.