Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239030
• Other study ID #: RP-BP-EF002
• Status: Completed
• Phase: Phase 3
• Start date: November 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2023
• Source: Rhodes Pharmaceuticals, L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

Description:

This is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose, phase 3 study to evaluate the safety and efficacy of Biphentin® methylphenidate hydrochloride (HCl) extended release (ER) capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years. The primary objective was to assess the efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV. Subjects who met study entry criteria were enrolled in the Double-blind Phase and were randomized to either a fixed dose of Biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule taken daily in the morning for 1 week. Subjects then continued into an Open-label Phase that included dose optimization with doses starting at 10 mg and allowed up to 60 mg. The open-label period following the one double-blind fixed dose week provides additional opportunity for subjects to receive treatment with Biphentin. Extra unscheduled dose optimization visits are allowed as needed for additional dose titration visits during the open-label period. The safety and tolerability, and efficacy assessments will be conducted throughout the study. Biphentin® is designed to be a single daily dose alternative to separate doses of immediate release methylphenidate by providing a biphasic plasma profile. It achieves a first Cmax more similar to immediate release methylphenidate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Males and females ages 6 up to 18
• 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 (WASI)
• Current primary psychiatric diagnosis of other listed disorders
• Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma
• Use of psychotropic central nervous system (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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
• Placebo
Placebo capsules

Locations

Country	Name	City	State
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	University of Cincinnati College of Medicine/PPSI	Cincinnati	Ohio
United States	University Hospital Case Medical Center	Cleveland	Ohio
United States	Department of Psychiatry, Duke University Medical Center	Durham	North Carolina
United States	University of California, Irvine/Child Development Center	Irvine	California
United States	Center for Psychiatry and Behavioural Medicine Inc	Las Vegas	Nevada
United States	Behavioral Clinical Research, Inc.	Lauderhill	Florida
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Precise Research Center	Madison	Mississippi
United States	Martin Kane, DO	Maitland	Florida
United States	South Shore Psychiatric Services, PC	Marshfield	Massachusetts
United States	Synergy Research	National City	California
United States	CTMG	New Bern	North Carolina
United States	New York State Psychiatric Institute/Columbia University	New York	New York
United States	Segal Institute for clinical Research, North Miami Outpatient Clinic	North Miami	Florida
United States	Wharton Research Center, Inc.	Wharton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Rhodes Pharmaceuticals, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3)	Change in ADHD-RS-IV Total Score from Baseline (Visit 2) to end of Double Blind Phase (Visit 3); [Calculations of baseline values (Visit 2) minus end of Double Blind values (Visit 3), higher differences means better outcomes].; Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): The home version of the ADHD-RS-IV comprising symptoms of ADHD was used. This 18-item scale incorporates each of the ADHD symptoms regardless of assigned subtype. Trained clinicians administered questionnaire to parents. Scoring was based on symptom severity on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Total Score is the sum of the scores for all 18 items, and could range from 0 (no impairment) to 54 (maximal impairment).	From baseline (visit 2) to end of of Double-Blind phase (visit 3)