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NCT02656160 · ClinicalTrials.gov registry record · Phase 2
Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT02656160: Completed Phase 2 study, sponsored by Brigham and Women's Hospital.
NCT02656160 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02656160, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study 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.
Primary Outcome
The EMG GG was quantified in arbitrary units derived from signal processing of the raw signal and as a percentage of wakefulness (%wake) for between-nights comparison of baseline sleep EMG GG activity. EMG GG analysis was performed on a breath-by-breath basis to identify a maximum value and a minimum value during inspiration and expiration, respectively (EMG GG peak and tonic). The difference between peak and tonic values was used to estimate respiratory related phasic activity. Wakefulness EMG
Interventions
- DRUG Placebo
- DRUG Dalfampridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT02656160 record still lists
NCT02656160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02656160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02656160 about?
NCT02656160 is a clinical study titled "Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults". 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.
What is the current status of trial NCT02656160?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2016-01. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02656160?
The interventions under investigation include: Placebo (DRUG), Dalfampridine (DRUG).
Who is sponsoring clinical trial NCT02656160?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02656160's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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