A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT01006122

Purpose

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.

Condition	Intervention	Phase
Excessive Daytime Sleepiness Narcolepsy	Drug: Placebo Drug: PF-03654746	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: narcolepsy

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from Baseline on the Maintenance of Wakefulness Test after 3 weeks of stable treatment. [ Time Frame: baseline and end of each Stable Dosing Phase ] [ Designated as safety issue: No ]
Vital signs, safety labs [ Time Frame: screening, baseline, each study visit ] [ Designated as safety issue: Yes ]
Electrocardiogram (ECG) [ Time Frame: screening, baseline, end of each stable dosing phase ] [ Designated as safety issue: Yes ]
Sheehan Suicidality Tracking Scale (STS) [ Time Frame: screening, baseline and each study visit ] [ Designated as safety issue: Yes ]
Adverse Event logs [ Time Frame: baseline and each study visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from Baseline on the Epworth Sleepiness Scale (ESS) at the end of each Titration Phase and after 3 weeks of stable treatment [ Time Frame: screening, baseline and each study visit ] [ Designated as safety issue: No ]
Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: baseline and each day of the study ] [ Designated as safety issue: No ]
Change from Baseline as measured by the SF-36 (Short-form Health Survey-36): Quality of LIfe scale [ Time Frame: baseline and end of each stable dosing phase ] [ Designated as safety issue: No ]
Change from Baseline in cataplexy episodes based upon patient diaries (to capture cataplexy episodes) after 3 weeks of stable treatment [ Time Frame: beginning at screening and each day of the study to end ] [ Designated as safety issue: No ]
Clinical Global Impression of Change (CGI-I) score [ Time Frame: screening, baseline and each study visit ] [ Designated as safety issue: No ]
CogState (computerized cognitive test battery) composite score and individual tests scores. [ Time Frame: baseline and each study visit ] [ Designated as safety issue: No ]
Change from Baseline on the Brief Fatigue Inventory (BFI) at the end of each Titration Phase and after 3 weeks of stable treatment [ Time Frame: Baseline, end of each Titration Phase, and after 3 wks stable treatment ] [ Designated as safety issue: No ]

Enrollment:	95
Study Start Date:	November 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	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.
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.	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.

Arms

Assigned Interventions

Placebo Comparator: Placebo

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.

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006122

Locations

United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85051
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
Pfizer Investigational Site
Orange, California, United States, 92868
United States, Florida
Pfizer Investigational Site
Brandon, Florida, United States, 33511
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33707
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Macon, Georgia, United States, 31201
United States, Illinois
Pfizer Investigational Site
Vernon Hills, Illinois, United States, 60061
United States, Kentucky
Pfizer Investigational Site
Crestview Hills, Kentucky, United States, 41017
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
United States, Mississippi
Pfizer Investigational Site
Hattiesburg, Mississippi, United States, 39402
Pfizer Investigational Site
Hattiesburg, Mississippi, United States, 39401
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Dublin, Ohio, United States, 43017
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78731
Pfizer Investigational Site
Houston, Texas, United States, 77063

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01006122 History of Changes
Other Study ID Numbers:	A8801015
Study First Received:	October 29, 2009
Last Updated:	May 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Randomized
double-blind
placebo-controlled
crossover study of PF-03654746 in Excessive Daytime Sleepiness associated with Narcolepsy

Additional relevant MeSH terms:

Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012