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NCT01986062 · ClinicalTrials.gov registry record · Phase 4
Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
A Phase 4 study, sponsored by Arbor Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
NCT01986062: Completed Phase 4 study, sponsored by Arbor Pharmaceuticals.
NCT01986062 is a Phase 4 study that has completed, run by Arbor Pharmaceuticals. The registered enrollment target is 97 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01986062, a Phase 4 study, has completed, sponsored by Arbor Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
Study Summary
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of each double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments.
Primary Outcome
Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale \[SKAMP\]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment
Interventions
- DRUG Placebo
- DRUG AR11
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT01986062 record still lists
NCT01986062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01986062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01986062 about?
NCT01986062 is a clinical study titled "Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting". This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks. Patients who achieve a stable...
What is the current status of trial NCT01986062?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2013-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01986062?
The interventions under investigation include: Placebo (DRUG), AR11 (DRUG).
Who is sponsoring clinical trial NCT01986062?
This trial is sponsored by Arbor Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01986062's enrollment target sits among peer trials
97 861st of 2000 higher than 1,138 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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