Clinical trial NCT01006122: A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Excessive Daytime Sleepiness
Narcolepsy
Keywords: Randomized
double-blind
placebo-controlled
crossover study of PF-03654746 in Excessive Daytime Sleepiness associated with Narcolepsy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase
timeFrame: Baseline, Day 21 of stable dosing phase
Secondary outcomes:
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
measure: Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
measure: Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase
timeFrame: Baseline, Day 7, 14, 21 of stable dosing phase
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase
timeFrame: Baseline, Day 21 of stable dosing phase
measure: Clinical Global Impression of Improvement (CGI-I) Scale Score
timeFrame: Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
measure: Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
measure: Computer Based Objective Cognition Testing (CogState) Detection Speed
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
measure: Computer Based Objective Cognition Testing (CogState) Identification Speed
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
measure: Computer Based Objective Cognition Testing (CogState) One Card Learning
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
measure: Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
measure: Computer Based Objective Cognition Testing (CogState ) Composite Score
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase
Other outcomes:
measure: Number of Participants With Vital Signs Data
timeFrame: Baseline up to 7-10 days after Day 21 (stable dosing phase)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Day 21 of stable dosing phase
measure: Number of Participants With Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Day 21 of stable dosing phase
measure: Medical Outcomes Study (MOS) Sleep Scale Score
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
measure: Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS)
timeFrame: Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Brandon
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Vernon Hills
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Hattiesburg
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Hattiesburg
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Dublin
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: