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

Completed · Phase 2 · Has a placebo group

Conditions studied: Excessive Daytime Sleepiness, Narcolepsy

In brief

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.

Key facts

Study ID

NCT01006122

Run by

Pfizer

People needed

95

Starts

2009-11-01

Expected to finish

2010-11-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• No other diagnosed sleep disorders (e.g., sleep apnea)
• Major medical disorders
• Major psychiatric disorders

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — Brandon, Florida, United States
• Pfizer Investigational Site — St. Petersburg, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Macon, Georgia, United States
• Pfizer Investigational Site — Vernon Hills, Illinois, United States
• Pfizer Investigational Site — Crestview Hills, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Hattiesburg, Mississippi, United States
• Pfizer Investigational Site — Hattiesburg, Mississippi, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Dublin, Ohio, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Columbia, South Carolina, United States
• Pfizer Investigational Site — Austin, Texas, United States
• Pfizer Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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