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NCT05972044 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 516
- Enrollment target
NCT05972044: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT05972044 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 516 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05972044, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 516 participants
- Enrollment target
Study Summary
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.
Primary Outcome
Adult ADHD Investigator Symptom Report Scale (AISRS)
Interventions
- DRUG Placebo
- DRUG Solriamfetol 150 mg
- DRUG Solriamfetol 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 516 participants |
| Start Date | 2023-07-06 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 3 |
What the finished NCT05972044 record still lists
NCT05972044 is an interventional study that assigns participants to a tested intervention. The registered 516 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 (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05972044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05972044 about?
NCT05972044 is a clinical study titled "A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)". FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.
What is the current status of trial NCT05972044?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 516 participants. The study started on 2023-07-06. Estimated completion is 2025-03-14.
What interventions are being tested in trial NCT05972044?
The interventions under investigation include: Placebo (DRUG), Solriamfetol 150 mg (DRUG), Solriamfetol 300 mg (DRUG).
Who is sponsoring clinical trial NCT05972044?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05972044's enrollment target sits among peer trials
516 724th of 2000 higher than 1,277 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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