NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654250
• Other study ID #: NWP09-ADHD-300
• Secondary ID: B7491005
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2012
• Last updated: January 4, 2016
• Start date: July 2012
• Est. completion date: October 2012

Study information

• Verified date: January 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• NWP09
Methylphenidate, variable dose, daily dosing, 1 week duration
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Woodland Community Church (Laboratory School)	Bradenton	Florida
United States	Bayou City Research, Ltd.	Houston	Texas
United States	Laboratory School	Huntington Beach	California
United States	UC Irvine - Hewitt Hall	Irvine	California
United States	UC Irvine Child Development Center	Irvine	California
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Westex Clinical Investigations	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Global Impression of Severity (CGI-S)	CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant's current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.	Baseline, Day 8, 15, 22, 29, 36, 43	No
Other	Clinical Global Impression-Improvement (CGI-I)	The CGI-I measured the participant's disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.	Day 8, 15, 22, 29, 36, 43	No
Other	Conners Parent Rating Scale (CPRS) Scores	CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.	Baseline, Day 8, 15, 22, 29, 36, 43	No
Primary	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.	0.75 up to 13 hours post-dose	No
Secondary	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.	0.75, 2, 4, 8, 10, 12, 13 hours post-dose	No
Secondary	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.	0.75, 2, 4, 8, 10, 12, 13 hours post-dose	No
Secondary	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.	0.75, 2, 4, 8, 10, 12 and 13 post-dose	No

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