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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Excessive Daytime Sleepiness; Narcolepsy

Treatments: Drug: PF-03654746; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006122

A8801015

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-03654746

Active Comparator group

Description:

At the end of the second arm of the study, the patient will have completed the study and have a 7-10 day follow-up visit.

Treatment:

Drug: PF-03654746