Phase 3
N=401
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02634346 ↗Enrolled (actual)
401
Serious AEs
0.5%
Results posted
Jun 2018
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 — -23.9; -22.8; -17.5 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALK3831 (Drug); Olanzapine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 |
-23.9; -22.8; -17.5 | <0.001 sig |
| SECONDARY Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4 |
-1.21; -1.27; -0.84 | 0.002 sig |
| SECONDARY Incidence of Adverse Events |
73; 73; 60 | — |
Summary
This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
- Meets criteria for the diagnosis of schizophrenia
- Resides in a stable living situation when not hospitalized
- Is willing and able to provide government-issued identification
- Additional criteria may apply
Exclusion Criteria
- Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
- Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
- Subject poses a current suicide risk
- Subject has a history of treatment resistance
- Subject has a history of poor or inadequate response to treatment with olanzapine
- Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
- Subject has a diagnosis of moderate or severe alcohol or drug use disorder
- Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT02634346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.