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NCT01006122 · ClinicalTrials.gov registry record · Phase 2
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT01006122: Completed Phase 2 study, sponsored by Pfizer.
NCT01006122 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01006122, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this compound compared to placebo in patients with narcolepsy is hypothesized.
Primary Outcome
MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.
Interventions
- DRUG Placebo
- DRUG PF-03654746
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT01006122 record still lists
NCT01006122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01006122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01006122 about?
NCT01006122 is a clinical study titled "A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy". Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this co...
What is the current status of trial NCT01006122?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2009-11. Estimated completion is 2010-11.
What interventions are being tested in trial NCT01006122?
The interventions under investigation include: Placebo (DRUG), PF-03654746 (DRUG).
Who is sponsoring clinical trial NCT01006122?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01006122's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 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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