Phase 2 N=13 Randomized Single-blind Treatment

Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults

Sleep Apnea, Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT02656160 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration). — 166; 136; 245; 163 percentage of wakefulness value — p=0.85

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Dalfampridine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration).	166; 136; 245; 163	0.85
SECONDARY Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O)	-0.23; -0.36	0.42

Summary

In this protocol the investigators will test the effect of dalfampridine (a potassium channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy control subjects.

Eligibility Criteria

Inclusion Criteria

Healthy control subjects

Exclusion Criteria

Cardiovascular disease other than well controlled hypertension
History of seizures

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02656160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.