drugset / Trial / NCT00748592
A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
RandomizedCrossoverDouble-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-06
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ATAGABALIN | Small molecule | 5 mg | — |
| Subject | ATAGABALIN | Small molecule | 15 mg | — |
| Subject | ATAGABALIN | Small molecule | 30 mg | — |