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Neu-P11 in Primary Insomnia
NCT01489969Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2011
- Primary completion
- May 2012
- Countries
- 1
- Sponsor
- Neurim Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- Piromelatine
- Conditions
- Insomnia
01
Overview
Phase 2, randomised, double-blind trial of Piromelatine in Insomnia (3 arms), sponsored by Neurim Pharmaceuticals. Primary endpoint: Latency to Persistent Sleep at 2 days. Started Dec 2011; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
20 mg
Neu-P11 20 mg daily
50 mg
Neu-P11 50 mg daily
Placebo
Matching placebo daily
03
Endpoints
Primary
Latency to Persistent Sleep
Secondary
Number of Awakenings
Duration of Wake After Sleep Onset
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