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CARNIVAL Type I: Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy (SMA) Type I

NCT00661453 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-06-15

Study results available
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Summary

This is a multi-center trial to test safety and evaluate early treatment intervention with valproic acid and carnitine in moderating SMA symptoms of Type I infants.

Conditions

  • Spinal Muscular Atrophy Type I

Interventions

DRUG

Valproic Acid and Levocarnitine

Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight

Sponsors & Collaborators

  • Families of Spinal Muscular Atrophy

    collaborator OTHER

  • Leadiant Biosciences, Inc.

    collaborator INDUSTRY

  • University of Utah

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

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 NCT00661453 on ClinicalTrials.gov