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Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy

NCT00481013 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2016-12-06

No results posted yet for this study

Summary

The primary objective of this proposal is to determine whether oral VPA is effective in treating SMA in adult patients.

Conditions

Interventions

DRUG

Valproic Acid (VPA)

Drug: Valproic Acid and Levocarnitine; capsules

DRUG

Placebo

For six months, pts are randomized into placebo or treatment. After 6 months, all pts are on treatment

Sponsors & Collaborators

Principal Investigators

  • John T Kissel · Ohio State University

  • Sandra P Reyna, M.D. · Families of Spinal Muscular Atrophy

  • Kathryn J Swoboda, M.D. · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-12-31
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT00481013 on ClinicalTrials.gov