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Attention Deficit Hyperactivity DisorderPhase 3NCT01654250

NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 3 study testing NWP09 in people with Attention Deficit Hyperactivity Disorder, run by Pfizer at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
NWP09
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
9 sitesUnited States
Study dates
Jul 2012to Oct 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Who cannot join

  • Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34201

  • Woodland Community Church (Laboratory School)

    Bradenton, Florida, 34202

  • Bayou City Research, Ltd.

    Houston, Texas, 77007

  • Laboratory School

    Huntington Beach, California, 92646

  • UC Irvine Child Development Center

    Irvine, California, 92612

  • UC Irvine - Hewitt Hall

    Irvine, California, 92697

  • Center for Psychiatry and Behavioral Medicine, Inc.

    Las Vegas, Nevada, 89128

  • Clinical Study Centers, LLC

    Little Rock, Arkansas, 72211

  • Westex Clinical Investigations

    Lubbock, Texas, 79423

Other trials in United States

About this study

Official title: A Multicenter, Dose-optimized, Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy Of Nwp09 In Pediatric Patients With Attention Deficit Hyperactivity Disorder (Adhd) In A Laboratory Classroom

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

Being tested
NWP09, Placebo
Keywords
ADHD, methylphenidate extended-release
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NWP09Drug

    Methylphenidate, variable dose, daily dosing, 1 week duration

  • PlaceboDrug

    Placebo

Study groups in NCT01654250
Study groupRoleWhat they receive
ActiveExperimentalNWP09
Receives: Drug: NWP09
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points

    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.

    Measured: 0.75 up to 13 hours post-dose

Secondary outcomes (3)

  1. Onset and Duration of Clinical Effect

    Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to [=<] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined 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 total possible combined score of 0 to 78; where higher score signified worst impairment.

    Measured: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose

  2. Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose

    SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.

    Measured: 0.75, 2, 4, 8, 10, 12, 13 hours post-dose

  3. Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose

    The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant's performance. The total score range from 0-160 with higher scores indicating better performance.

    Measured: 0.75, 2, 4, 8, 10, 12 and 13 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01654250
Sponsor's protocol ID
NWP09-ADHD-300
Other IDs
B7491005
Status last verified
Jan 2016
First submitted
27 Apr 2012
Last updated
3 Feb 2016
Data monitoring committee
No

Publications

  • Wigal SB, Childress A, Berry SA, Belden H, Walters F, Chappell P, Sherman N, Orazem J, Palumbo D. Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017 Oct;27(8):690-699. doi: 10.1089/cap.2016.0177. Epub 2017 May 30.

    PubMed 28557548

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NWP09 in people with Attention Deficit Hyperactivity Disorder, run by Pfizer at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points (time frame: 0.75 up to 13 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01654250, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016; AzTrials last refreshed its copy on 31 Oct 2026.

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