Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-03654746 · 2 trials · 3 indications
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.
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
| 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. |
| Flexible Dose | EXPERIMENTAL | - |
| Fixed Dose | EXPERIMENTAL | - |
| 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. |
| Placebo capsules | DRUG | Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment 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...
PF-03654746 is an investigational small molecule being developed for excessive daytime sleepiness associated with narcolepsy and for attention deficit hyperactivity disorder (ADHD). It has been studied in Phase 2 clinical trials for both conditions, though it is not approved and remains in clinical development.
PF-03654746 is being developed by Pfizer, Inc. (NYSE: PFE). The company has sponsored Phase 2 clinical trials evaluating the drug in adults with ADHD and in patients with excessive daytime sleepiness associated with narcolepsy.
PF-03654746 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in adults with ADHD and one in patients with excessive daytime sleepiness associated with narcolepsy. The drug is investigational and has not been approved by regulatory authorities.
PF-03654746 has been studied in two completed Phase 2 trials: NCT00531752, which evaluated two doses in adults with ADHD (66 participants), and NCT01006122, which evaluated the drug for excessive daytime sleepiness associated with narcolepsy (95 participants). Both trials were randomized, double-blind, and placebo-controlled.
PF-03654746 is a distinct investigational compound developed by Pfizer. No alternative names have been reported for this drug in the available clinical trial information.