Overview

A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
Summary
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this compound compared to placebo in patients with narcolepsy is hypothesized.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- ISDC diagnosis of narcolepsy

- Excessive Daytime Sleepiness in association with a diagnosis of narcolepsy

- An MWT (Maintenance of Wakefulness Test) average sleep latency of under 15 minutes at
Baseline

Exclusion Criteria:

- No other diagnosed sleep disorders (e.g., sleep apnea)

- Major medical disorders

- Major psychiatric disorders