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NCT00931164 · ClinicalTrials.gov registry record · Phase 1
Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00931164: Completed Phase 1 study, sponsored by University of Utah.
NCT00931164 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931164, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
WHO: The investigators are recruiting children and young adults to participate in a research study who: 1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC) 2. Are between the ages of 6 months - 25 years old 3. Have at least three 10-minute-long AHC episodes during a typical week 4. Can commit to 12 weeks of completing of a daily log describing AHC episodes and to a multi-night hospital stay at the University of Utah Center for Clinical and Translational Science (CCTS) WHY: The goal of this study is to evaluate whether the study drug can safely and effectively decrease AHC episodes and improve the quality of life of individuals with AHC. WHAT and WHERE: This study involves at least 12 weeks of completing and submitting daily AHC Episode Logs and a five-day hospital stay at the University of Utah CCTS. There are 4 phases of the study, and they include: 1. Six weeks of daily log completion prior to starting study drug 2. Five day stay at the University of Utah CCTS 3. Six additional weeks of daily log completion while using study drug at home 4. One day clinic visit to the University of Utah for follow up COMPENSATION: There is no fee to participate. All procedures performed specifically for this study will be covered by the study and will not be billed to you or your insurance company. The study drug will be dispensed to you free of charge. Meals and lodging at the study site will be provided free of charge for the study participant and one care provider. Additionally, the research team will assist subjects with booking and obtaining free transportation, such as an airline tickets, to and from the study site.
Interventions
- DRUG Sodium Oxybate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT00931164 record still lists
NCT00931164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium Oxybate is the first listed.
NCT00931164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00931164 about?
NCT00931164 is a clinical study titled "Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)". WHO: The investigators are recruiting children and young adults to participate in a research study who: 1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC) 2. Are between the ages of 6 months - 25 years old 3. Have at least three 10-minute-long AHC episodes during a typical week 4...
What is the current status of trial NCT00931164?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2009-08. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00931164?
The interventions under investigation include: Sodium Oxybate (DRUG).
Who is sponsoring clinical trial NCT00931164?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00931164's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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