Status:
COMPLETED
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
Lead Sponsor:
Rhodes Pharmaceuticals, L.P.
Conditions:
Attention Deficit Hyperactivity Disorder
ADHD
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief 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 pedi...
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 (HCl) extende...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT01239030
Start Date
November 1 2010
End Date
March 1 2012
Last Update
February 22 2023
Active Locations (16)
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1
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
2
University of California, Irvine/Child Development Center
Irvine, California, United States, 92612
3
Synergy Research
National City, California, United States, 91950
4
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34201