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NCT03605680 · ClinicalTrials.gov registry record · Phase 3
A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 604
- Enrollment target
NCT03605680: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03605680 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 604 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605680, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 604 participants
- Enrollment target
Study Summary
This study evaluates the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD). Participants will either receive a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.
Primary Outcome
The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.
Interventions
- OTHER Placebo
- DRUG Centanafadine SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 604 participants |
| Start Date | 2019-01-16 |
| Est. Completion | 2020-04-11 |
| Phase | Phase 3 |
What the finished NCT03605680 record still lists
NCT03605680 is an interventional study that assigns participants to a tested intervention. The registered 604 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03605680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03605680 about?
NCT03605680 is a clinical study titled "A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder". This study evaluates the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD). Participants will either receive a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.
What is the current status of trial NCT03605680?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 604 participants. The study started on 2019-01-16. Estimated completion is 2020-04-11.
What interventions are being tested in trial NCT03605680?
The interventions under investigation include: Placebo (OTHER), Centanafadine SR (DRUG).
Who is sponsoring clinical trial NCT03605680?
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 NCT03605680's enrollment target sits among peer trials
604 607th of 2000 higher than 1,394 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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