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NCT00607542 · ClinicalTrials.gov registry record · Phase 1
Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT00607542 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 61 participants.
The verdict
NCT00607542, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2008-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00607542
The ClinicalTrials.gov registry entry for NCT00607542 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which baclofen is the first listed.
NCT00607542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00607542 about?
NCT00607542 is a clinical study titled "Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity". 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 ...
What is the current status of trial NCT00607542?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2008-11. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00607542?
The interventions under investigation include: baclofen (DRUG).
Who is sponsoring clinical trial NCT00607542?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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