Back to resultsTime Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
Primary Purpose
Attention Deficit Hyperactivity Disorder, ADHD
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate Hydrochloride Extended Release Capsule
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention deficit, Hyperactivity, Impulsivity, Inattention
Eligibility Criteria
Inclusion Criteria:
- Males and females ages 6 to 12.
- ADHD diagnosis with ADHD-RS-IV scores ≥ 90th percentile.
- In need of treatment for ADHD and able to have 2-day washout from previous medication.
- Females of child-bearing potential not pregnant and practice birth control.
- Subject and parent/guardian willing to comply with protocol.
- Signed consent and assent.
Exclusion Criteria:
- IQ less than 80 WASI.
- Current primary psychiatric diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of Tourette's Syndrome.
- Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
- Use of psychotropic CNS meds having effect exceeding 14 days from screening.
- Planned use of prohibited drugs.
- Is pregnant or breast-feeding.
- Significant ECG or laboratory abnormalities.
- Experimental drug or medical device within 30 days prior to screening.
- Hypersensitivity to methylphenidate.
- Inability or unwillingness to comply with protocol.
- Well controlled on current ADHD treatment.
- Inability to take oral capsules.
Sites / Locations
- University of California, Irvine/Child Development Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Open Label Phase Then 2-week Double Blind Phase (Placebo First, Then Methylphenidate HCl ER Capsule)
Open Label Phase Then 2-week Double Blind Phase (Methylphenidate HCl ER Capsule First, Then Placebo)
Arm Description
Open Label Phase: Subjects were dose optimized over a 2 to 4 week period. All subjects began at an initial Methylphenidate hydrochloride extended release capsules dose of 15 mg and were titrated weekly to an optimal dose using strengths of 15, 20, 30, up to the maximum of 40 mg/day. Double Blind Phase (2-weeks): Placebo: Capsule without active drug for 1 week Methylphenidate HCl ER Capsule: An optimized dose of Methylphenidate hydrochloride extended release capsules (15, 20, 30, or 40 mg) for 1 week Dosed once daily in the morning
Open Label Phase: Subjects were dose optimized over a 2 to 4 week period. All subjects began at an initial Methylphenidate hydrochloride extended release capsules dose of 15 mg and were titrated weekly to an optimal dose using strengths of 15, 20, 30, up to the maximum of 40 mg/day. Double Blind Phase (2-weeks): Methylphenidate HCl ER Capsule: An optimized dose of Methylphenidate hydrochloride extended release capsules (15, 20, 30, or 40 mg) for 1 week Placebo: Capsule without active drug for 1 week Dosed once daily in the morning
Outcomes
Primary Outcome Measures
Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales
Comparison of Swanson, Kotkin, Alger, M-Flynn and Pelham (SKAMP) Combined, Attention, and Deportment Scales following drug dose versus placebo.
The SKAMP scale is a validated rating scale that assesses behavioral symptoms of ADHD in a classroom setting using a 7-point impairment scale (0 = none through 6 = maximal impairment). The SKAMP total score comprises 13 items, with individual total scores ranging from 0 to 78 (lower scores mean better outcome). The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.
Secondary Outcome Measures
Comparison Following Treatment With Drug or Placebo Using PERMP (Permanent Product of Arithmetic) Evaluations
Comparison of PERMP measurement scores following drug dose versus placebo (math-correct).
The Permanent Product Measure of Performance (PERMP), is a 5-page test consisting of 80 math problems per page (total of 400 problems) and evaluates effortful performance in the classroom as a measure of efficacy. Participants are instructed to work at their seats and to complete as many problems as possible in 10 minutes. The appropriate level of difficulty for each student was determined previously based on results of a math pretest administered at screening. Performance was evaluated using PERMP-A) and PERMP-C scores.
Measures obtained from these tests include the number of problems attempted (Math-Attempted; PERMP-A) and the number of problems answered correctly (Math-Correct; PERMP-C). Higher scores are better. The responses are reviewed by comparing them to an answer template, and they are triple-checked for accuracy
Full Information
NCT ID
NCT01269463
First Posted
December 31, 2010
Last Updated
November 16, 2022
Sponsor
Rhodes Pharmaceuticals, L.P.
1. Study Identification
Unique Protocol Identification Number
NCT01269463
Brief Title
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
Official Title
A Randomized, Double-Blind Study of the Time Course of Response to Biphentin® Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2011 (Actual)
Primary Completion Date
June 18, 2011 (Actual)
Study Completion Date
March 13, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhodes Pharmaceuticals, L.P.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with Attention deficit hyperactivity disorder (ADHD) for the substantial day.
Detailed Description
Biphentin methylphenidate hydrochloride (HCl) extended release (ER) capsules is provided in multiple strengths of 10, 15, 20, 30, 40, 50, and 60 mg to be administered once daily. Once daily dosing is intended to provide treatment for the substantial day.
For current analog classroom study each eligible subject will be optimized at 15, 20, 30, or 40 mg in a timeframe of five weekly periods. In the sixth week each subject will be randomized double-blind to receive either active comparator at the optimized dose or placebo comparator treatment. The first classroom session will be held at the end of the week, when efficacy measurements including Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) and Permanent Product Measure of Performance (PERMP) tests will be administered. At the beginning of the following week, the subjects will be crossed-over to the corresponding active comparator or placebo comparator treatment. The second classroom session will be held at the end of the second double-blind week, when the same efficacy measurements will be administered.
Various safety and tolerability, and quality of life assessments will be conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, ADHD
Keywords
Attention deficit, Hyperactivity, Impulsivity, Inattention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
All subjects entered the Open-Label Dose optimization phase and were titrated until an optimized dose of Methylphenidate hydrochloride Extended Release capsule was achieved. Completing subjects then entered the randomized Double-blind Phase (crossover).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label Phase Then 2-week Double Blind Phase (Placebo First, Then Methylphenidate HCl ER Capsule)
Arm Type
Experimental
Arm Description
Open Label Phase: Subjects were dose optimized over a 2 to 4 week period. All subjects began at an initial Methylphenidate hydrochloride extended release capsules dose of 15 mg and were titrated weekly to an optimal dose using strengths of 15, 20, 30, up to the maximum of 40 mg/day.
Double Blind Phase (2-weeks):
Placebo: Capsule without active drug for 1 week Methylphenidate HCl ER Capsule: An optimized dose of Methylphenidate hydrochloride extended release capsules (15, 20, 30, or 40 mg) for 1 week Dosed once daily in the morning
Arm Title
Open Label Phase Then 2-week Double Blind Phase (Methylphenidate HCl ER Capsule First, Then Placebo)
Arm Type
Experimental
Arm Description
Open Label Phase: Subjects were dose optimized over a 2 to 4 week period. All subjects began at an initial Methylphenidate hydrochloride extended release capsules dose of 15 mg and were titrated weekly to an optimal dose using strengths of 15, 20, 30, up to the maximum of 40 mg/day.
Double Blind Phase (2-weeks):
Methylphenidate HCl ER Capsule: An optimized dose of Methylphenidate hydrochloride extended release capsules (15, 20, 30, or 40 mg) for 1 week Placebo: Capsule without active drug for 1 week Dosed once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Hydrochloride Extended Release Capsule
Other Intervention Name(s)
Biphentin®
Intervention Description
An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Biphentin placebo
Intervention Description
Capsule without active drug
Primary Outcome Measure Information:
Title
Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales
Description
Comparison of Swanson, Kotkin, Alger, M-Flynn and Pelham (SKAMP) Combined, Attention, and Deportment Scales following drug dose versus placebo.
The SKAMP scale is a validated rating scale that assesses behavioral symptoms of ADHD in a classroom setting using a 7-point impairment scale (0 = none through 6 = maximal impairment). The SKAMP total score comprises 13 items, with individual total scores ranging from 0 to 78 (lower scores mean better outcome). The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, and staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention and evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing.
Time Frame
Average over all post-dose time points (1.0, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5, and 12 hours)
Secondary Outcome Measure Information:
Title
Comparison Following Treatment With Drug or Placebo Using PERMP (Permanent Product of Arithmetic) Evaluations
Description
Comparison of PERMP measurement scores following drug dose versus placebo (math-correct).
The Permanent Product Measure of Performance (PERMP), is a 5-page test consisting of 80 math problems per page (total of 400 problems) and evaluates effortful performance in the classroom as a measure of efficacy. Participants are instructed to work at their seats and to complete as many problems as possible in 10 minutes. The appropriate level of difficulty for each student was determined previously based on results of a math pretest administered at screening. Performance was evaluated using PERMP-A) and PERMP-C scores.
Measures obtained from these tests include the number of problems attempted (Math-Attempted; PERMP-A) and the number of problems answered correctly (Math-Correct; PERMP-C). Higher scores are better. The responses are reviewed by comparing them to an answer template, and they are triple-checked for accuracy
Time Frame
12 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ages 6 to 12.
ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile.
In need of treatment for ADHD and able to have 2-day washout from previous medication.
Females of child-bearing potential not pregnant and practice birth control.
Subject and parent/guardian willing to comply with protocol.
Signed consent and assent.
Exclusion Criteria:
Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence.
Current primary psychiatric diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of Tourette's Syndrome.
Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
Use of psychotropic CNS meds having effect exceeding 14 days from screening.
Planned use of prohibited drugs.
Is pregnant or breast-feeding.
Significant ECG or laboratory abnormalities.
Experimental drug or medical device within 30 days prior to screening.
Hypersensitivity to methylphenidate.
Inability or unwillingness to comply with protocol.
Well controlled on current ADHD treatment.
Inability to take oral capsules.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-wei Chang, Ph.D.
Organizational Affiliation
NuTec Incorporated
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sharon B. Wigal, Ph.D.
Organizational Affiliation
University of California, Irvine / Child Development Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Kupper, Ph.D.
Organizational Affiliation
Rhodes Pharmaceuticals, L.P.
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Irvine/Child Development Center
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
25470572
Citation
Wigal SB, Greenhill LL, Nordbrock E, Connor DF, Kollins SH, Adjei A, Childress A, Stehli A, Kupper RJ. A randomized placebo-controlled double-blind study evaluating the time course of response to methylphenidate hydrochloride extended-release capsules in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 Dec;24(10):562-9. doi: 10.1089/cap.2014.0100.
Results Reference
derived
Learn more about this trial
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
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