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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Excessive Daytime Sleepiness, Narcolepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- Major medical disorders

- Major psychiatric disorders

NCT01006122
Pfizer
Completed
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy

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Excessive Daytime Sleepiness, Narcolepsy
NCT01006122
All Genders
18+
Years
Multiple Sites
A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
A Randomized Phase 2, Double Blind, Placebo-Controlled, Multi-Center Crossover Study Of PF-03654746 As A Daily Treatment For Excessive Daytime Sleepiness (EDS) Associated With Narcolepsy
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Excessive Daytime Sleepiness
  • Narcolepsy
  • Drug: Placebo
    Patients receiving placebo will undergo the same procedures as those receiving active treatment. Each patient will receive matching placebo tablets in a fixed dose escalation schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at 1.0 mg; decrease to 0.5 mg or increase to 2.0 mg based upon the clinicians judgment regarding efficacy and side effects at the 1.0 dose level. The patient will then remain at the determined dose for a 3 week stable dosing period, with a 7 (-2/+ 9) day wash out and then crossover to repeat the same sequence for the second arm of the study.
  • Drug: PF-03654746
    Each patient will receive PF-03654746 tablets in a fixed dose titration schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at the 1.0 mg dose; decrease to 0.50 mg or increase to 2.0 mg based upon the clinician's judgement regarding efficacy and side effects at the 1.0 mg dose. The patient will remain at the determined dose for a 3 week stable dosing period.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: PF-03654746
    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.
    Intervention: Drug: PF-03654746
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01006122
A8801015
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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