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NCT04461119 · ClinicalTrials.gov registry record · Phase 2
Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia
A Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT04461119: Completed Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
NCT04461119 is a Phase 2 study that has completed, run by Newron Pharmaceuticals SPA. The registered enrollment target is 138 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04461119, a Phase 2 study, has completed, sponsored by Newron Pharmaceuticals SPA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study Summary
This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.
Primary Outcome
Comparison will be made between the evenamide and placebo groups in the proportion of patients experiencing Serious Adverse Events \[SAEs\], Adverse Events leading to discontinuation \[ADOs\] and, Treatment-Emergent Adverse Events \[TEAEs\].
Interventions
- DRUG Placebo
- DRUG Evenamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2021-03-13 |
| Phase | Phase 2 |
What the finished NCT04461119 record still lists
NCT04461119 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04461119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04461119 about?
NCT04461119 is a clinical study titled "Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia". This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.
What is the current status of trial NCT04461119?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2020-06-16. Estimated completion is 2021-03-13.
What interventions are being tested in trial NCT04461119?
The interventions under investigation include: Placebo (DRUG), Evenamide (DRUG).
Who is sponsoring clinical trial NCT04461119?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04461119's enrollment target sits among peer trials
138 525th of 2000 higher than 1,474 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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