Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
NCT ID: NCT01269463
Last Updated: 2022-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
26 participants
INTERVENTIONAL
2011-01-19
2013-03-13
Brief Summary
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Detailed Description
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For current analog classroom study each eligible subject will be optimized at 15, 20, 30, or 40 mg in a timeframe of five weekly periods. In the sixth week each subject will be randomized double-blind to receive either active comparator at the optimized dose or placebo comparator treatment. The first classroom session will be held at the end of the week, when efficacy measurements including Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) and Permanent Product Measure of Performance (PERMP) tests will be administered. At the beginning of the following week, the subjects will be crossed-over to the corresponding active comparator or placebo comparator treatment. The second classroom session will be held at the end of the second double-blind week, when the same efficacy measurements will be administered.
Various safety and tolerability, and quality of life assessments will be conducted.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Open Label Phase Then 2-week Double Blind Phase (Placebo First, Then Methylphenidate HCl ER Capsule)
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
Methylphenidate Hydrochloride Extended Release Capsule
An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily
Placebo
Capsule without active drug
Open Label Phase Then 2-week Double Blind Phase (Methylphenidate HCl ER Capsule First, Then Placebo)
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
Methylphenidate Hydrochloride Extended Release Capsule
An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily
Placebo
Capsule without active drug
Interventions
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Methylphenidate Hydrochloride Extended Release Capsule
An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily
Placebo
Capsule without active drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile.
3. In need of treatment for ADHD and able to have 2-day washout from previous medication.
4. Females of child-bearing potential not pregnant and practice birth control.
5. Subject and parent/guardian willing to comply with protocol.
6. Signed consent and assent.
Exclusion Criteria
2. 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.
3. Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
4. Use of psychotropic CNS meds having effect exceeding 14 days from screening.
5. Planned use of prohibited drugs.
6. Is pregnant or breast-feeding.
7. Significant ECG or laboratory abnormalities.
8. Experimental drug or medical device within 30 days prior to screening.
9. Hypersensitivity to methylphenidate.
10. Inability or unwillingness to comply with protocol.
11. Well controlled on current ADHD treatment.
12. Inability to take oral capsules.
6 Years
12 Years
ALL
No
Sponsors
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Rhodes Pharmaceuticals, L.P.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei-wei Chang, Ph.D.
Role: STUDY_DIRECTOR
NuTec Incorporated
Sharon B. Wigal, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine / Child Development Center
Robert Kupper, Ph.D.
Role: STUDY_CHAIR
Rhodes Pharmaceuticals, L.P.
Locations
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University of California, Irvine/Child Development Center
Irvine, California, United States
Countries
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References
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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.
Other Identifiers
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RP-BP-EF001
Identifier Type: -
Identifier Source: org_study_id