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Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes

NCT00887562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-10-26

Study results available
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Summary

The purpose of this study is to compare the efficacy of two (2) different doses of idebenone with that of a placebo over a one month period on cerebral lactate concentration as measured by magnetic resonance spectroscopy.

Conditions

  • MELAS Syndrome

Interventions

DRUG

Idebenone

900 mg/day for 1 month

DRUG

Idebenone

2250 mg/day for 1 month

OTHER

Placebo

Placebo - No idebenone

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    collaborator INDUSTRY

  • Michio Hirano

    lead OTHER

Principal Investigators

  • Michio Hirano, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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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 NCT00887562 on ClinicalTrials.gov