Trial record 1 of 1 for:
NCT02694328
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
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| ClinicalTrials.gov Identifier: NCT02694328 |
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Recruitment Status :
Completed
First Posted : February 29, 2016
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
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Sponsor:
Alkermes, Inc.
Information provided by (Responsible Party):
Alkermes, Inc.
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Brief Summary:
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: ALKS 3831 Drug: Olanzapine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 561 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia |
| Actual Study Start Date : | March 2, 2016 |
| Actual Primary Completion Date : | November 7, 2018 |
| Actual Study Completion Date : | November 7, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Schizophrenia
| Arm | Intervention/treatment |
|---|---|
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Experimental: ALKS 3831
Administered as a coated bilayer tablet
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Drug: ALKS 3831
Daily dosing |
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Active Comparator: Olanzapine
Administered as a coated bilayer tablet
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Drug: Olanzapine
Daily dosing |
Primary Outcome Measures :
- Percent Change From Baseline in Body Weight at Week 24 [ Time Frame: Baseline and Week 24 ]
- Percentage of Participants With >/= 10% Weight Gain at Week 24 [ Time Frame: Baseline and Week 24 ]
Secondary Outcome Measures :
- Percentage of Participants With >/= 7% Weight Gain at Week 24 [ Time Frame: Baseline and Week 24 ]
- Number of Participants Experiencing of Adverse Events (AEs) [ Time Frame: 24 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2
- Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
- Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
- Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
- Additional criteria may apply
Exclusion Criteria:
- Subject has any of the following psychiatric conditions per DSM-5 criteria:
- Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
- Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
- Drug-induced or toxic psychosis
- Any other psychiatric condition that could interfere with participation in the study
- Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
- Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
- Additional criteria may apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694328
Locations
Show 54 study locations
Sponsors and Collaborators
Alkermes, Inc.
Investigators
| Study Director: | Alkermes Medical Director | Alkermes, Inc. |
Study Documents (Full-Text)
Documents provided by Alkermes, Inc.:
Documents provided by Alkermes, Inc.:
Study Protocol [PDF] September 18, 2018
Statistical Analysis Plan [PDF] September 18, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT02694328 |
| Other Study ID Numbers: |
ALK3831-A303 |
| First Posted: | February 29, 2016 Key Record Dates |
| Results First Posted: | February 10, 2020 |
| Last Update Posted: | February 10, 2020 |
| Last Verified: | January 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Alkermes, Inc.:
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Alkermes ALKS 3831 Samidorphan |
Schizophrenia Olanzapine Weight |
Additional relevant MeSH terms:
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |