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

NCT00931164 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-03-31

Study results available
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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

DRUG

Sodium Oxybate

dosage is by weight

Sponsors & Collaborators

Principal Investigators

  • Kathryn J. Swoboda, M.D. · University of Utah/Primary Children's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-01-31
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931164 on ClinicalTrials.gov