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Modafinil to Treat Fatigue in People With Mitochondrial Disease
NCT07887412Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Dec 2026
- Primary completion
- Jan 2029
- Countries
- 1
- Drugs
- modafinil
- Conditions
- mitochondrial disease
01
Overview
Phase 3, randomised, double-blind trial of modafinil in mitochondrial disease (2 arms). Primary endpoint: 6-Minute Walk Test Distance at 98 days. Planned start Dec 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Modafinil followed by placebo
Cycle 1 Modafinil vs Cycle 2 Placebo
Placebo followed by modafinil
Cycle 1 Placebo vs Cycle 2 Modafinil
03
Who it enrols
Patients aged 6-60 years with a confirmed diagnosis of mitochondrial disease, clinically significant fatigue, and the ability to walk independently for at least 15 meters.
04
Endpoints
Primary
6-Minute Walk Test Distance
Secondary
10-Metre Walk Assessment Distance
Fatigue Severity Scale
Modified Fatigue Impact Scale
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