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NCT01269463 · ClinicalTrials.gov registry record · Phase 3
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
A Phase 3 study, sponsored by Rhodes Pharmaceuticals, L.P..
- Completed
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
NCT01269463: Completed Phase 3 study, sponsored by Rhodes Pharmaceuticals, L.P..
NCT01269463 is a Phase 3 study that has completed, run by Rhodes Pharmaceuticals, L.P.. The registered enrollment target is 26 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01269463, a Phase 3 study, has completed, sponsored by Rhodes Pharmaceuticals, L.P..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
Comparison of Swanson, Kotkin, Alger, M-Flynn and Pelham (SKAMP) Combined, Attention, and Deportment Scales following drug dose versus placebo. The SKAMP scale is a validated rating scale that assesses behavioral symptoms of ADHD in a classroom setting using a 7-point impairment scale (0 = none through 6 = maximal impairment). The SKAMP total score comprises 13 items, with individual total scores ranging from 0 to 78 (lower scores mean better outcome). The SKAMP-D subscale evaluates deportment,
Interventions
- DRUG Placebo
- DRUG Methylphenidate Hydrochloride Extended Release Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-01-19 |
| Est. Completion | 2013-03-13 |
| Phase | Phase 3 |
What the finished NCT01269463 record still lists
NCT01269463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01269463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01269463 about?
NCT01269463 is a clinical study titled "Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting". 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 provi...
What is the current status of trial NCT01269463?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2011-01-19. Estimated completion is 2013-03-13.
What interventions are being tested in trial NCT01269463?
The interventions under investigation include: Placebo (DRUG), Methylphenidate Hydrochloride Extended Release Capsule (DRUG).
Who is sponsoring clinical trial NCT01269463?
This trial is sponsored by Rhodes Pharmaceuticals, L.P., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01269463's enrollment target sits among peer trials
26 1937th of 2000 higher than 60 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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