Phase 3
Completed N=26
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
Source: ClinicalTrials.gov NCT01269463 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales — 1.46; 2.03 units on a scale — p=<0.01
◆ Published Evidence
Established
38citations · ~3 / year
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.
Summary
The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with Attention deficit hyperactivity disorder (ADHD) for the substantial day.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison Following Treatment Between Drug and Placebo Using Evaluation by SKAMP Combined, Attention, and Deportment Scales |
1.46; 2.03 | <0.01 sig |
| SECONDARY Comparison Following Treatment With Drug or Placebo Using PERMP (Permanent Product of Arithmetic) Evaluations |
92.85; 80.30; 86.85; 74.80 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females ages 6 to 12.
- 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.
- 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.
- Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
- Use of psychotropic 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.
Data sourced from ClinicalTrials.gov (NCT01269463) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.