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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 is a Phase 2 study that has completed, run by Neurim Pharmaceuticals. The registered enrollment target is 137 participants.
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).
Interventions
- DRUG Neu-P11
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01489969
The ClinicalTrials.gov registry entry for NCT01489969 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurim Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neu-P11 is the first listed.
NCT01489969 reports 0 study locations.
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.
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