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Dalfampridine on Genioglossus Muscle Activity in Healthy Controls
NCT02656160Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2016
- Primary completion
- May 2016
- Countries
- 1
- Sponsor
- Brigham and Women's Hospital
- Modality
- Small Molecules
- Drugs
- dalfampridine
- Conditions
- obstructive sleep apnea (OSA)
01
Overview
Phase 2, randomised, double-blind trial in obstructive sleep apnea (OSA) comparing Dalfampridine with Placebo (2 arms). Primary endpoint: Genioglossus Activity During Sleep Expressed as %Wakefulness Value. Started Jan 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dalfampridine
Dalfampridine 10 mg extended release administered 3 hours before sleep
Placebo
Placebo administered 3 hours before sleep
03
Who it enrols
Healthy control subjects without cardiovascular disease (except well-controlled hypertension) or history of seizures.
04
Endpoints
Primary
Genioglossus Activity During Sleep Expressed as %Wakefulness Value
Secondary
Change in EMG GG for cmH2O Change in Epiglottic Pressure
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