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NCT01654250 · ClinicalTrials.gov registry record · Phase 3

NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
90
Enrollment target

NCT01654250: Completed Phase 3 study, sponsored by Pfizer.

NCT01654250 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01654250, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
90 participants
Enrollment target

Study Summary

The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

Primary Outcome

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

Interventions

  • DRUG Placebo
  • DRUG NWP09

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2012-07
Est. Completion 2012-10
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT01654250 record still lists

NCT01654250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01654250 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01654250 about?

NCT01654250 is a clinical study titled "NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)". The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

What is the current status of trial NCT01654250?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2012-07. Estimated completion is 2012-10.

What interventions are being tested in trial NCT01654250?

The interventions under investigation include: Placebo (DRUG), NWP09 (DRUG).

Who is sponsoring clinical trial NCT01654250?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01654250's enrollment target sits among peer trials

90 1724th of 2000 higher than 263 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01654250, the US trial registry maintained by the National Library of Medicine. NCT01654250 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.