Trial intelligence / Profile preview

Idebenone in Duchenne Muscular Dystrophy (DELOS)

NCT01027884Phase 3

Key facts

Status: Completed
Start: Jul 2009
Primary completion: Jan 2014
Countries: 10
Sponsor: Santhera Pharmaceuticals
Modality: Small Molecules

Drugs: idebenone
Conditions: Duchenne muscular dystrophy (DMD)

Overview

Phase 3, randomised, double-blind trial in Duchenne muscular dystrophy (DMD) comparing Idebenone Arm with Placebo Arm (2 arms). Primary endpoint: Peak Expiratory Flow percent predicted at 52 weeks. Started Jul 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Idebenone Arm
Idebenone 900 mg/day (2 tablets x 3 times/day)
Placebo Arm
Matching Placebo

Endpoints

Primary

Peak Expiratory Flow percent predicted52 weeks

Secondary

Forced Vital Capacity percent predicted52 weeks
Muscle Strength52 weeks
Pediatric Quality of Life Inventory52 weeks
Adverse Events52 weeks

Beyond the preview

Go deeper on NCT01027884.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01027884.