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A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
NCT02669758 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
Conditions Studied
Interventions
- DRUG ALKS 3831
Study Locations (20)
Other
- Alkermes Investigational Site — Burgas
- Alkermes Investigational Site — Kazanlak
- Alkermes Investigational Site — Lovech
- Alkermes Investigational Site — Novi Iskar
- Alkermes Investigational Site — Plovdiv
- Alkermes Investigational Site — Sofia
California
- Alkermes Investigational Site — Culver City
- Alkermes Investigational Site — Garden Grove
- Alkermes Investigational Site — Lemon Grove
- Alkermes Investigational Site — Orange
- Alkermes Investigational Site — San Diego
Arkansas
- Alkermes Investigational Site — Little Rock
- Alkermes Investigational Site — Springdale
Florida
- Alkermes Investigational Site — Miami
Illinois
- Alkermes Investigational Site — Chicago
Missouri
- Alkermes Investigational Site — St Louis
Nevada
- Alkermes Investigational Site — Las Vegas
New Jersey
- Alkermes Investigational Site — Marlton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2016-01-20 |
| Est. Completion | 2018-06-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02669758
The ClinicalTrials.gov registry entry for NCT02669758 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 281 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention — of which ALKS 3831 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02669758 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02669758 about?
NCT02669758 is a clinical study titled "A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia". The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
What is the current status of trial NCT02669758?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 281 participants. The study started on 2016-01-20. Estimated completion is 2018-06-29.
What conditions does trial NCT02669758 study?
This clinical trial studies the following conditions: Schizophrenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02669758?
The interventions under investigation include: ALKS 3831 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02669758?
This trial is sponsored by Alkermes, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02669758 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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