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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier:
NCT01239030
First received: November 3, 2010
Last updated: January 22, 2013
Last verified: January 2013

November 3, 2010
January 22, 2013
November 2010
February 2012   (final data collection date for primary outcome measure)
Efficacy of Biphentin compared to placebo [ Time Frame: At end of Double-Blind Week 1 ] [ Designated as safety issue: No ]
Efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the Clinician ADHD-RS-IV in children and adolescents (aged 6 to 18) diagnosed with ADHD
Same as current
Complete list of historical versions of study NCT01239030 on ClinicalTrials.gov Archive Site
Incidence of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: During the 12-week study period ] [ Designated as safety issue: Yes ]
Incidence of adverse findings using various measures of safety, tolerability, and quality of life assessments following administration of once daily Biphentin
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
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)

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

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 extended release capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.

The study will have four phases: (1) Screening and washout; (2) Double-blind fixed dose study involving test drug at 10, 15, 20 or 40 mg/day or placebo for 1 week; (3) Open-label phase that includes dose optimization with doses starting at 10 mg, and allowed up to 60 mg; and (4) 30-day safety follow-up. Eight (8) visits may be required. 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.

Various safety and tolerability, and quality of life assessments will be conducted.

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. It also comes in eight (8), that allow better individualized dosing.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • ADHD
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
  • Biphentin
  • Methylphenidate Hydrochloride Extended Release Capsules
  • Active Comparator: 10 mg
    Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
    Intervention: Drug: Methylphenidate Hydrochloride Extended Release Capsules
  • Active Comparator: 15 mg
    Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
    Intervention: Drug: Methylphenidate Hydrochloride Extended Release Capsules
  • Active Comparator: 20 mg
    Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
    Intervention: Drug: Methylphenidate Hydrochloride Extended Release Capsules
  • Active Comparator: 40 mg
    Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
    Intervention: Drug: Methylphenidate Hydrochloride Extended Release Capsules
  • Placebo Comparator: Placebo
    Placebo Capsules
    Intervention: Drug: Methylphenidate Hydrochloride Extended Release Capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
March 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females ages 6 up to 18
  • 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 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
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01239030
RP-BP-EF002
No
Rhodes Pharmaceuticals, L.P.
Rhodes Pharmaceuticals, L.P.
Not Provided
Study Director: Wei-wei Chang, Ph.D. NuTec Incorporated
Principal Investigator: Laurence Greenhill, M.D. New York State Psychiatric Institute / Columbia University
Principal Investigator: Sharon B. Wigal, Ph.D. University of California, Irvine / Child Development Center
Study Chair: Robert J. Kupper, Ph.D. Rhodes Phamaceuticals, L.P.
Rhodes Pharmaceuticals, L.P.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP