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NCT03324581 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 239
- Enrollment target
NCT03324581: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03324581 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 239 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03324581, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 239 participants
- Enrollment target
Study Summary
A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
Primary Outcome
The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). It includes a 9-item inattentive symptom subscale and a 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of ind
Interventions
- DRUG Placebo
- DRUG Atomoxetine
- DRUG OPC-64005
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2017-11-09 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 2 |
What the finished NCT03324581 record still lists
NCT03324581 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03324581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03324581 about?
NCT03324581 is a clinical study titled "The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder". A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
What is the current status of trial NCT03324581?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2017-11-09. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT03324581?
The interventions under investigation include: Placebo (DRUG), Atomoxetine (DRUG), OPC-64005 (DRUG).
Who is sponsoring clinical trial NCT03324581?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03324581's enrollment target sits among peer trials
239 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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