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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 is a Phase 4 study that has completed, run by Arbor Pharmaceuticals. The registered enrollment target is 97 participants.
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.
Interventions
- DRUG Placebo
- DRUG AR11
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01986062
The ClinicalTrials.gov registry entry for NCT01986062 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arbor Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01986062 reports 0 study locations.
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.
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