Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
This study has been completed.
Sponsor:
Rhodes Pharmaceuticals, L.P.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder ADHD |
Drug: Methylphenidate Hydrochloride Extended Release Capsules |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Rhodes Pharmaceuticals, L.P.:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 236 |
| Study Start Date: | November 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 10 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg
|
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
|
|
Active Comparator: 15 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg
|
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
|
|
Active Comparator: 20 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg
|
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
|
|
Active Comparator: 40 mg
Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg
|
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
|
|
Placebo Comparator: Placebo
Placebo Capsules
|
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Biphentin Methylphenidate ER Once-A-Day Capsules
Other Names:
|
Detailed 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 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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239030
Locations
| United States, Arkansas | |
| Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| University of California, Irvine/Child Development Center | |
| Irvine, California, United States, 92612 | |
| Synergy Research | |
| National City, California, United States, 91950 | |
| United States, Florida | |
| Florida Clinical Research Center, LLC | |
| Bradenton, Florida, United States, 34201 | |
| Behavioral Clinical Research, Inc. | |
| Lauderhill, Florida, United States, 33319 | |
| Martin Kane, DO | |
| Maitland, Florida, United States, 32751 | |
| Segal Institute for clinical Research, North Miami Outpatient Clinic | |
| North Miami, Florida, United States, 33161 | |
| United States, Massachusetts | |
| South Shore Psychiatric Services, PC | |
| Marshfield, Massachusetts, United States, 02050 | |
| United States, Mississippi | |
| Precise Research Center | |
| Madison, Mississippi, United States, 39110 | |
| United States, Nevada | |
| Center for Psychiatry and Behavioural Medicine Inc | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New York | |
| New York State Psychiatric Institute/Columbia University | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Department of Psychiatry, Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| CTMG | |
| Newbern, North Carolina, United States, 28562 | |
| United States, Ohio | |
| University of Cincinnati College of Medicine/PPSI | |
| Cincinnati, Ohio, United States, 45219 | |
| University Hospital Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| Wharton Research Center, Inc. | |
| Wharton, Texas, United States, 77488 | |
Sponsors and Collaborators
Rhodes Pharmaceuticals, L.P.
Investigators
| 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. |
More Information
No publications provided
| Responsible Party: | Rhodes Pharmaceuticals, L.P. |
| ClinicalTrials.gov Identifier: | NCT01239030 History of Changes |
| Other Study ID Numbers: | RP-BP-EF002 |
| Study First Received: | November 3, 2010 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Rhodes Pharmaceuticals, L.P.:
|
inattention impulsivity hyperactivity ADHD |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013