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

NCT01006122 | Completed Phase 2 Results

• 1 other identifier: A8801015
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 21

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.

Conditions

Excessive Daytime Sleepiness; Narcolepsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase

  MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.

  Baseline, Day 21 of stable dosing phase

Secondary Outcomes (11)

• 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

  Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

• 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

  Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

• Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase

  Baseline, Day 7, 14, 21 of stable dosing phase

• Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase

  Baseline, Day 21 of stable dosing phase

• Clinical Global Impression of Improvement (CGI-I) Scale Score

  Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase

Other Outcomes (5)

• Number of Participants With Vital Signs Data

  Baseline up to 7-10 days after Day 21 (stable dosing phase)

• Number of Participants With Laboratory Abnormalities

  Baseline up to Day 21 of stable dosing phase

• Number of Participants With Electrocardiogram (ECG) Findings

  Baseline up to Day 21 of stable dosing phase

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

PF-03654746

ACTIVE COMPARATOR

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

Interventions

Placebo DRUG

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.

Placebo

PF-03654746 DRUG

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.

PF-03654746

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• No other diagnosed sleep disorders (e.g., sleep apnea)
• Major medical disorders
• Major psychiatric disorders

Sponsors & Collaborators

• Pfizer: lead

Study Sites (21)

Pfizer Investigational Site

Phoenix, Arizona, 85006, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85051, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Brandon, Florida, 33511, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33707, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Macon, Georgia, 31201, United States

Location

Pfizer Investigational Site

Vernon Hills, Illinois, 60061, United States

Location

Pfizer Investigational Site

Crestview Hills, Kentucky, 41017, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

Location

Pfizer Investigational Site

Hattiesburg, Mississippi, 39401, United States

Location

Pfizer Investigational Site

Hattiesburg, Mississippi, 39402, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Dublin, Ohio, 43017, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29201, United States

Location

Pfizer Investigational Site

Austin, Texas, 78731, United States

Location

Pfizer Investigational Site

Houston, Texas, 77063, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Narcolepsy

Interventions

N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 2, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 9, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-04

Locations

US (21)