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

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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

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

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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