CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Idebenone +2 moredrug
Likely dose
Idebenone 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00887562
NCT00887562Phase 2Completed
CompareCT.gov

A Phase IIa Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis and Stroke-like Episodes

Michio Hirano·interventional·Posted Apr 24, 2009·Updated Oct 26, 2016

In Brief

A Phase 2 clinical trial evaluating Idebenone and Placebo for MELAS Syndrome. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMELAS Syndrome
CountriesUnited States
CollaboratorsSanthera Pharmaceuticals

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2009
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.2 years ago

Interventions

Idebenonedrug

900 mg/day for 1 month

Idebenonedrug

2250 mg/day for 1 month

Placeboother

Placebo - No idebenone