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NCT01489969 · ClinicalTrials.gov registry record · Phase 2
Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
A Phase 2 study, sponsored by Neurim Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
NCT01489969: Completed Phase 2 study, sponsored by Neurim Pharmaceuticals.
NCT01489969 is a Phase 2 study that has completed, run by Neurim Pharmaceuticals. The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01489969, a Phase 2 study, has completed, sponsored by Neurim Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
Study Summary
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia patients aged 18-80 years, following the first two nights (immediate effect) and at the end of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The secondary endpoints are number of awakenings after sleep onset and the duration of wake after sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings).
Primary Outcome
The primary efficacy parameter is Latency to persistent sleep (LPS) measured by the PSG at the first two nights (immediate effect) of the double blind treatment period. LPS was summarized at baseline and after two days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the two days was compared, adjusting for the baselinescore. An ANCOVA model was used. Lower score indicates reduct
Interventions
- DRUG Neu-P11
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01489969 record still lists
NCT01489969 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Neu-P11 is the first listed.
NCT01489969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01489969 about?
NCT01489969 is a clinical study titled "Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients". This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to assess the efficacy of N...
What is the current status of trial NCT01489969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2011-12. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01489969?
The interventions under investigation include: Neu-P11 (DRUG).
Who is sponsoring clinical trial NCT01489969?
This trial is sponsored by Neurim Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01489969's enrollment target sits among peer trials
137 527th of 2000 higher than 1,474 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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