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 was studied for excessive daytime sleepiness associated with narcolepsy and for attention deficit hyperactivity disorder in adults. It is an investigational small molecule developed by Pfizer and has been tested in Phase 2 clinical trials. It is not an approved treatment for either condition.
PF-03654746 targets the histamine H3 receptor, also known as HRH3. It acts as an antagonist at this receptor. By blocking HRH3, the drug is designed to modulate histamine signaling, which is involved in wakefulness and attention regulation.
PF-03654746 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trials evaluating the compound in excessive daytime sleepiness associated with narcolepsy and in adult attention deficit hyperactivity disorder.
PF-03654746 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 trials have been completed, and no active trials are currently listed for this compound.
PF-03654746 has been evaluated in two completed Phase 2 trials. NCT01006122 studied it for excessive daytime sleepiness associated with narcolepsy in 95 participants. NCT00531752 studied two doses in adults with attention deficit hyperactivity disorder in 66 participants. Both were randomized, double-blind, and placebo-controlled.