A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
NCT ID: NCT01006122
Last Updated: 2014-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2009-11-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Major medical disorders
* Major psychiatric disorders
18 Years
55 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Other Identifiers
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A8801015
Identifier Type: -
Identifier Source: org_study_id
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