SANTHERA PHARMACEUTICALS (USA), INC.

🇺🇸United States

Country: 🇺🇸United States

Ownership: Private

Employees: -

Market Cap: $123.5M

Website

Clinical Trials

A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids

Phase 3

Terminated

Conditions: Duchenne Muscular Dystrophy (DMD)

Interventions: Drug: placebo
Drug: Idebenone 150 mg film-coated tablets

First Posted Date: 2016-06-27

Last Posted Date: 2021-12-03

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 255

Registration Number: NCT02814019

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Rare Disease Research, Atlanta, Georgia, United States
🇺🇸
Childrens Hospital of Los Angeles, Los Angeles, California, United States

and more 60 locations

Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

Completed

Conditions: Leber's Hereditary Optic Neuropathy (LHON)

First Posted Date: 2016-06-10

Last Posted Date: 2020-01-30

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 219

Registration Number: NCT02796274

Locations: 🇧🇪
Universitair Ziekenhuis Gent, Gent, Belgium
🇧🇪
C. H. U. Sart Tilman, Liege, Belgium
🇫🇷
CHU Angers - Hôpital Hôtel Dieu, Angers, France

and more 18 locations

Study to Assess the Efficacy and Safety of Raxone in LHON Patients

Phase 4

Completed

Conditions: Leber's Hereditary Optic Neuropathy (LHON)

Interventions: Drug: Idebenone

First Posted Date: 2016-05-16

Last Posted Date: 2023-04-21

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 199

Registration Number: NCT02774005

Locations: 🇬🇧
University Hospital of Wales, Cardiff, United Kingdom
🇪🇸
Institut Catala de Retina, Barcelona, Spain
🇪🇸
Hospital Universitario Ramon y Cajal, Madrid, Spain

and more 26 locations

Post Authorisation Safety Study With Raxone in LHON Patients

Completed

Conditions: Leber's Hereditary Optic Neuropathy (LHON)

Interventions: Drug: Idebenone

First Posted Date: 2016-05-13

Last Posted Date: 2021-07-16

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 229

Registration Number: NCT02771379

Locations: 🇮🇹
Ospedale San Raffaele, Milano, Italy
🇩🇪
Universitaetsklinikum Essen, Essen, Germany
🇫🇷
CHU Amiens - Centre Saint Victor, Amiens, Somme, France

and more 23 locations

Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

Completed

Conditions: Leber Hereditary Optic Neuropathy (LHON)

First Posted Date: 2013-07-08

Last Posted Date: 2014-05-15

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 306

Registration Number: NCT01892943

Locations: 🇸🇮
University Eye Clinic, Ljubljana, Slovenia
🇮🇹
Fondazione G.B. Bietti, Rome, Italy
🇫🇷
CIC/CMR CHNO des Quinze-Vingts, Paris, France

and more 5 locations

Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)

Phase 1

Completed

Conditions: Congenital Muscular Dystrophy

Interventions: Drug: Omigapil

First Posted Date: 2013-03-05

Last Posted Date: 2021-09-24

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 20

Registration Number: NCT01805024

Locations: 🇺🇸
NINDS, Bethesda, Maryland, United States

Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

Phase 3

Withdrawn

Conditions: Leber's Hereditary Optic Neuropathy

Interventions: Drug: Idebenone
Drug: Placebo

First Posted Date: 2011-12-20

Last Posted Date: 2014-08-22

Lead Sponsor: Santhera Pharmaceuticals

Registration Number: NCT01495715

RHODOS Follow-up Single-visit Study

Completed

Conditions: Leber's Hereditary Optic Neuropathy

First Posted Date: 2011-08-22

Last Posted Date: 2013-05-27

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 60

Registration Number: NCT01421381

Locations: 🇬🇧
Biomedical Research Centre, The Medical School, Newcastle upon Tyne, United Kingdom
🇩🇪
Friedrich Baur Institut Neurologische Klinik und Poliklinik, München, Germany
🇨🇦
Hôpital Notre-Dame (CHUM), Montreal,, Quebec, Canada

Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)

Phase 3

Completed

Conditions: Friedreich's Ataxia

Interventions: Drug: Placebo
Drug: Idebenone

First Posted Date: 2011-02-24

Last Posted Date: 2016-03-09

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 29

Registration Number: NCT01303406

Locations: 🇬🇧
The National Hospital, University College London, London, United Kingdom

Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

Phase 3

Completed

Conditions: Muscular Dystrophy, Duchenne
Ambulatory Care

Interventions: Drug: Placebo
Drug: Idebenone

First Posted Date: 2009-12-09

Last Posted Date: 2015-10-19

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 65

Registration Number: NCT01027884

Locations: 🇺🇸
University of California Davis Medical Center, Sacramento, California, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States
🇺🇸
Carolinas Medical Center, Neurosciences and Spine Institute, Charlotte, North Carolina, United States

and more 20 locations

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