Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NWP09 · 1 trial · 1 indication
The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | NWP09 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| NWP09 | DRUG | Methylphenidate, variable dose, daily dosing, 1 week duration |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition Exclusion Criteria: * Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
NWP09 is an investigational small molecule being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
NWP09 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Attention Deficit Hyperactivity Disorder.
NWP09 is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug remains investigational and has not received regulatory approval for any indication.
NWP09 has one completed Phase 3 clinical trial, NCT01654250, titled 'NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)'. This randomized, double-blind, placebo-controlled study enrolled 90 participants aged 6 years and older in the United States.
No alternative names for NWP09 have been disclosed. The drug is identified solely by its code name NWP09 in clinical trial registries and development programs.