Phase 3
Completed N=230
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
Source: ClinicalTrials.gov NCT01239030 ↗Enrolled (actual)
230
Serious AEs
0.4%
Results posted
Feb 2023
Primary outcomePrimary: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) — 9.3; 11.2; 12.3; 13.2 units on a scale — p=0.0046
◆ Published Evidence
Established
28citations · ~3 / year
Efficacy of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR™) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Phase III, Randomized, Double-Blind Study.
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 pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.
Linked Publications
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Efficacy of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR™) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Phase III, Randomized, Double-Blind Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) |
9.3; 11.2; 12.3; 13.2; 5.1 | 0.0046 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01239030) 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.