These trials completed more than 12 months ago and should have reported results.

These trials are not yet due to report results: some are ongoing, some completed within the past 12 months.

These trials have problematic data on the registry. Details why »

Status Trial ID Title Completion date Category
Completed, but no date, and reported results 2005-002520-33 A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dy... bad-data
Reported results 2005-004083-22 A Phase III double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of Friedreich's Ataxia patients. 2010-01-29 due-trials
Reported results 2006-002679-42 A double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of patients with Leber's Hereditary Optic Neuropathy 2010-02-19 due-trials
Reported results 2007-001646-40 A Phase III Open-Label, Single-Group Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients 2012-07-16 due-trials
Completed, but no date, and reported results 2007-007752-34 A Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular Dystrophy bad-data
Reported results 2009-012037-30 A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy Studio randomizz... 2014-05-09 due-trials
Listed as ongoing, but also has a completion date and reported results 2010-023388-16 A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich’s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study) 2012-07-19 bad-data
Reported results 2011-001034-42 A single visit, observational, follow-up study of Patients with Leber’s Hereditary Optic Neuropathy following participation in SNT-II-003 trial 2011-12-05 due-trials
Reported results 2015-004405-16 External Natural History Controlled, open-Label Intervention Study to Assess the Efficacy and Safety of Long-Term Treatment with Raxone® in Leber?s Hereditary Optic Neuropathy (LHON) Estudio de int... 2021-09-23 due-trials
Reported results 2016-000602-10 A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroi... 2020-10-05 due-trials
Exempt Terminated 2016-005110-22 Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis not-yet-due
Listed as ongoing, but also has a completion date and reported results 2017-004279-30 A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study 2020-10-05 bad-data
Exempt, with results 2018-002550-71 Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis 2020-12-30 not-yet-due

Related organisations

Over time organisations can merge, or split.

We think Santhera Pharmaceuticals LLC is now also responsible for the trials of: