Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)

Santhera

Status and phase

Completed

Phase 2

Conditions

Duchenne Muscular Dystrophy

Treatments

Drug: Idebenone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00758225

SN T-II-001-E

Details and patient eligibility

About

The scientific aim of the present extension study is to monitor long-term safety and tolerability of idebenone in patients with DMD. Furthermore, the long-term effect on respiratory, cardiac and motor functions, and skeletal muscle strength/function will be assessed.

Enrollment

21 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

Completion of study SNT-II-001
Body weight ≥ 25 kg
Glucocorticosteroids and ACE-inhibitors are allowed, if on stable dosage within 2 months prior to inclusion
Eligibility to participate in the present extension study as confirmed by the investigator

Exclusion criteria

Safety or tolerability issues arising during the course of SNT-II-001 which in the opinion of the investigator preclude further treatment with idebenone
Clinically significant abnormalities of haematology or biochemistry
Abuse of drugs or alcohol
Use of coenzyme Q10 or idebenone within 30 days prior to inclusion
Intake of any investigational drug within 30 days prior to inclusion
Symptomatic heart failure
Previous history of ventricular arrhythmias (other than isolated ventricular extrasystole); ventricular arrhythmias presented at baseline
Known individual hypersensitivity to idebenone or to any of the excipients