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NCT02634346 · ClinicalTrials.gov registry record · Phase 3
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 403
- Enrollment target
NCT02634346: Completed Phase 3 study, sponsored by Alkermes.
NCT02634346 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 403 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02634346, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 403 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
Primary Outcome
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
Interventions
- DRUG Placebo
- DRUG Olanzapine
- DRUG ALK3831
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-06-07 |
| Phase | Phase 3 |
What the finished NCT02634346 record still lists
NCT02634346 is an interventional study that assigns participants to a tested intervention. The registered 403 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 (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02634346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02634346 about?
NCT02634346 is a clinical study titled "A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)". This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
What is the current status of trial NCT02634346?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2015-12. Estimated completion is 2017-06-07.
What interventions are being tested in trial NCT02634346?
The interventions under investigation include: Placebo (DRUG), Olanzapine (DRUG), ALK3831 (DRUG).
Who is sponsoring clinical trial NCT02634346?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02634346's enrollment target sits among peer trials
403 917th of 2000 higher than 1,082 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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