NCT00931164

Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)

Single-center Phase I/II Trial of Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO Trial)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 6 Months – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alternating Hemiplegia of Childhood

Interventions

Type	Name	Description
DRUG	Sodium Oxybate	dosage is by weight

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-01-01
• Completion: 2011-09-01
• First posted: 2009-07-02
• Last updated: 2014-03-31
• Results posted: 2014-03-31

Locations

1 site across 1 country: United States