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Safety and Efficacy Study of A0001 in Patients With the A3243G Mitochondrial DNA Point Mutation

NCT01074359 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-04-22

No results posted yet for this study

Summary

This is a phase 2a, double-blind, placebo-controlled, single-center study. Twenty-one patients who qualify for the study will be randomly assigned to either active drug or placebo. The study will take place at Newcastle University. Patients will have a 66% chance of getting active drug. Patients will be required to take study treatment orally twice a day for 28 days. A baseline visit will occur within 21 days of screening visit. All patients will be followed for 1 week after completion of study or early withdrawal from the study.

Conditions

Interventions

DRUG

A0001 (alpha-tocopherolquinone)

28 days (1.5 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.

DRUG

Placebo

28 days of placebo oral capsules. Treatment taken twice daily with meals.

Sponsors & Collaborators

  • Penwest Pharmaceuticals Co.

    lead INDUSTRY

Principal Investigators

  • Patrick F Chinnery · University of Newcastle Upon-Tyne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT01074359 on ClinicalTrials.gov