Excessive Somnolence Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VSF-173 and Matching Placebo in Healthy Male and Female Subjects With Induced Excessive Sleepiness
| NCT number | NCT00467441 |
| Other study ID # | VP-VSF-173-2001 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | April 26, 2007 |
| Last updated | October 31, 2007 |
The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Healthy subjects with no medical, psychiatric, or current sleep disorders - Subject must sign a written consent form Exclusion Criteria: - Evidence of excessive daytime sleepiness - History of sleep disorders - Psychiatric or neurological disorders |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Vanda Investigational Site | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Vanda Pharmaceuticals |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT) | |||
| Secondary | Mood | |||
| Secondary | Psychomotor performance | |||
| Secondary | Safety and tolerability |