At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Dalfampridine 10 mg extended release, single dose 3 hours before sleepAI-extracted
Key inclusion· 1
- ✓Healthy control subjects
Key exclusion· 2
- ✕Cardiovascular disease other than well controlled hypertension
- ✕History of seizures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects
In Brief
A Phase 2 clinical trial evaluating Placebo and Dalfampridine for Sleep Apnea, Obstructive. Completed, enrolled 13 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Obstructive
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedJan 2016
Primary CompletionMay 2016
Study CompletionJul 2016
TodayJul 2026
First PostedJan 14, 2016
Enrollment StartJan 1, 2016
Primary CompletionMay 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.5 years ago
Interventions
Placebodrug
Placebo 3 hrs before sleep
Dalfampridinedrug
Dalfampridine 10 mg extended release 3 hrs before sleep