Clinical Studies
The following list is designed to provide up-to-date information on our on-going clinical studies. It is intended primarily to help patients, their carers and physicians to know which clinical trials are active. The company has a policy to post its clinical trials on ClinicalTrials.gov.
DELOS - Catena® for the treatment of Duchenne Muscular Dystrophy
The DELOS (DuchEnne Muscular Dystrophy Long-term IdebenOne Study) study is a double-blind, randomized, placebo-controlled clinical trial evaluating the safety, tolerability and efficacy of one dose of Catena® (idebenone, 900 mg/day) compared to placebo.
The Phase III study is ongoing, but not recruiting patients. For more information about DELOS, please visit www.clinicaltrials.gov (Identifier NCT01027884) or www.mda.org.
MELTIMI - Catena® for treatment of MELAS
The MELTIMI (MELAS Trial of Idebenone using MRS) trial is a Phase II double-blind, placebo-controlled study investigating the safety and efficacy of two doses of Catena® versus placebo.
The study is sponsored and conducted by the Columbia University Medical Center, New York.
The Phase II study is ongoing, but not recruiting patients. For more information about MELTIMI, please visit www.clinicaltrials.gov (Identifier NCT00887562).
IPPOMS - Catena® for treatment of Primary Progressive Multiple Sclerosis
The IPPOMS (Idebenone in Patients with Primary Progressive Multiple Sclerosis) trial is a Phase II study with a 12-month pre-treatment baseline period followed by a double-blind, randomized, placebo-controlled treatment of 24 months duration investigating the safety and efficacy of high dose Catena® versus placebo.
This study is sponsored and conducted by the National Institute of Neurological Disorders and Stroke (NINDS).
The Phase II study is currently recruiting participants. For more information about IPPOMS, please visit www.clinicaltrials.gov (Identifier NCT00950248) or contact the study center in the United States:
US National Institutes of Health
Clinical Center
Patient Recruitment and Public Liaison Office
9000 Rockville Pike
Bethesda, Maryland, 20892
Phone: +1 800 411-1222
prpl@mail.cc.nih.gov