A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01006122
First received: October 29, 2009
Last updated: April 9, 2013
Last verified: April 2013
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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 2 |
| 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:
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.
|
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: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01006122 History of Changes |
| Other Study ID Numbers: | A8801015 |
| Study First Received: | October 29, 2009 |
| Last Updated: | April 9, 2013 |
| 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 June 18, 2013