Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01006122 | A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy | PHASE2 | COMPLETED | 95 | — | — | Nov 1, 2009 | Nov 1, 2010 | May 9, 2014 | 21 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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 ap...