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Dichloroacetate for MELAS

Phase 2

Waitlist Available

Led By Darryl C De Vivo, MD

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic with MELAS, including previous seizure or stroke

Patients with A3243G mtDNA point mutation or maternally related to someone who has the mutation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test whether the drug dichloroacetate can improve the symptoms of MELAS, a syndrome which causes severe mental impairment.

Who is the study for?

This trial is for individuals with MELAS syndrome, specifically those who have the A3243G mtDNA point mutation or are related to someone who does. Participants should have experienced symptoms like seizures or strokes and must be able to follow the study's procedures.Check my eligibility

What is being tested?

The trial is testing dichloroacetate (DCA) for its potential to alleviate symptoms of MELAS syndrome. The focus is on whether DCA can improve mental functioning in patients affected by this condition.See study design

What are the potential side effects?

While not explicitly stated, common side effects of DCA may include nerve damage (neuropathy), fatigue, nausea, and changes in liver function. Specific side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have MELAS and have had seizures or strokes.

Select...

I have the A3243G mitochondrial DNA mutation or am related to someone who does.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor

1,965 Previous Clinical Trials

2,672,762 Total Patients Enrolled

1 Trials studying MELAS Syndrome

22 Patients Enrolled for MELAS Syndrome

Darryl C De Vivo, MDPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

134 Total Patients Enrolled

Media Library

Dichloroacetate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00068913 — Phase 2

MELAS Syndrome Clinical Trial 2023: Dichloroacetate Highlights & Side Effects. Trial Name: NCT00068913 — Phase 2

Dichloroacetate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00068913 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapeutic intervention attained authorization from the FDA?

"With the existing evidence at hand, our team rated the safety of the treatment a 2. We have yet to collect data that confirms its efficacy, which is why this trial is classified as Phase 2."

Answered by AI

Is this clinical trial open to people above the age of 35?

"To be included in this research, participants must have an age between 6 and 0. There are 375 trials for minors and 985 for geriatrics."

Answered by AI

Is there an opportunity for me to partake in this research?

"35 individuals suffering from melas syndrome between the ages of 6 and 0 are being enrolled into this trial. Candidates need to either have the A3243G mtDNA point mutation, or be related by birth to someone who does."

Answered by AI

Are there any openings left for prospective participants in this research?

"The information posted on clinicaltrials.gov indicates that this experiment is no longer recruiting patients; it was first announced in March 2000 and its most recent update occurred in June 2005. Despite the closure of this trial, there are more than 1,300 other medical studies currently enrolling participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome

2000. "Evaluating the Effectiveness of a Dichloroacetate in MELAS Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00068913.