Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting

NCT01269463 | Completed Phase 3 Results

• 1 other identifier: RP-BP-EF001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; ADHD

Keywords

Attention deficit; Hyperactivity; Impulsivity; Inattention

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Comparison Following Treatment With Drug or Placebo Using PERMP (Permanent Product of Arithmetic) Evaluations

  12 hours post-dose

Study Arms (2)

Open Label Phase Then 2-week Double Blind Phase (Placebo First, Then Methylphenidate HCl ER Capsule)

EXPERIMENTAL

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

Drug: Methylphenidate Hydrochloride Extended Release Capsule; Drug: Placebo

Open Label Phase Then 2-week Double Blind Phase (Methylphenidate HCl ER Capsule First, Then Placebo)

EXPERIMENTAL

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

Drug: Methylphenidate Hydrochloride Extended Release Capsule; Drug: Placebo

Interventions

Methylphenidate Hydrochloride Extended Release Capsule DRUG

An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily

Also known as: Biphentin®

Open Label Phase Then 2-week Double Blind Phase (Methylphenidate HCl ER Capsule First, Then Placebo); Open Label Phase Then 2-week Double Blind Phase (Placebo First, Then Methylphenidate HCl ER Capsule)

Placebo DRUG

Capsule without active drug

Also known as: Biphentin placebo

Open Label Phase Then 2-week Double Blind Phase (Methylphenidate HCl ER Capsule First, Then Placebo); Open Label Phase Then 2-week Double Blind Phase (Placebo First, Then Methylphenidate HCl ER Capsule)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhodes Pharmaceuticals, L.P.: lead

Study Sites (1)

University of California, Irvine/Child Development Center

Irvine, California, 92612, United States

Location

Related Publications (1)

• 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.

  PMID: 25470572 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm; Impulsive Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Inder Chaudhary, PhD
• Organization: Rhodes Pharmaceuticals L.P.

inder.chaudhary@rhodespharma.com

401-262-9272

Study Officials

• Wei-wei Chang, Ph.D.

  NuTec Incorporated

  STUDY DIRECTOR

• Sharon B. Wigal, Ph.D.

  University of California, Irvine / Child Development Center

  PRINCIPAL INVESTIGATOR

• Robert Kupper, Ph.D.

  Rhodes Pharmaceuticals, L.P.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 31, 2010
• First Posted: January 4, 2011
• Study Start: January 19, 2011
• Primary Completion: June 18, 2011
• Study Completion: March 13, 2013
• Last Updated: December 13, 2022
• Results First Posted: December 13, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)