Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia (ERUDITE)
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| ClinicalTrials.gov Identifier: NCT05182476 |
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Recruitment Status :
Recruiting
First Posted : January 10, 2022
Last Update Posted : January 23, 2023
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Sponsor:
Neurocrine Biosciences
Information provided by (Responsible Party):
Neurocrine Biosciences
- Study Details
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Brief Summary:
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Placebo Drug: Luvadaxistat | Phase 2 |
A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS). The study will enroll approximately 308 adult participants with schizophrenia. In addition, the study will evaluate the long-term safety and tolerability of treatment with luvadaxistat. The expected duration of study participation for each participant is approximately 72 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 308 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment |
| Actual Study Start Date : | December 7, 2021 |
| Estimated Primary Completion Date : | February 2024 |
| Estimated Study Completion Date : | March 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Schizophrenia
MedlinePlus related topics:
Schizophrenia
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo daily
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Drug: Placebo
Oral tablets |
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Experimental: Luvadaxistat treatment schedule 1
Luvadaxistat daily
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Drug: Luvadaxistat
Oral tablets
Other Names:
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Experimental: Luvadaxistat treatment schedule 2
Luvadaxistat daily
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Drug: Luvadaxistat
Oral tablets
Other Names:
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Primary Outcome Measures :
- Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score [ Time Frame: Baseline to Day 98 ]
Secondary Outcome Measures :
- Change From Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Score [ Time Frame: Baseline to Day 98 ]
- Change From Baseline on the Continuous Performance Test-Identical Pairs (CPT-IP) Test [ Time Frame: Baseline to Day 98 ]
- Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) Test [ Time Frame: Baseline to Day 98 ]
- Change From Baseline on the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [ Time Frame: Baseline to Day 98 ]
- Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [ Time Frame: Baseline to Day 98 ]
- Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score [ Time Frame: Baseline to Day 98 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
Participants must meet all of the following inclusion criteria:
- Completed written informed consent
- Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.
- Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- The initial diagnosis of schizophrenia must be ≥1 year before screening.
- The participant is currently receiving a stable regimen of psychotropic medications
- Participant has stable symptomatology ≥3 months before the screening visit.
- The participant must have an adult informant.
- A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m^2), inclusive.
Key Exclusion Criteria
Participants will be excluded from the study if they meet any of the following criteria:
- Pregnant or breastfeeding or plans to become pregnant during the study.
- Exhibit more than a minimal level of extrapyramidal signs/symptoms .
- Schizophrenia diagnosis occurred before 12 years of age.
- Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder.
- Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions.
- Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 6 months before screening.
- Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening.
- Positive drug screen for disallowed substances
- Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments.
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): NCT05182476
Contacts
| Contact: Neurocrine Medical Information Call Center | 877-641-3461 | medinfo@neurocrine.com |
Locations
| United States, Arizona | |
| Neurocrine Clinical Site | Recruiting |
| Phoenix, Arizona, United States, 85012 | |
| United States, Arkansas | |
| Neurocrine Clinical Site | Recruiting |
| Bentonville, Arkansas, United States, 72712 | |
| United States, California | |
| Neurocrine ClinicalSite | Recruiting |
| Bellflower, California, United States, 90706 | |
| Neurocrine Clinical Site | Recruiting |
| Culver City, California, United States, 90230 | |
| Neurocrine Clinical Site | Recruiting |
| Garden Grove, California, United States, 92845 | |
| Neurocrine Clinical Site | Recruiting |
| Glendale, California, United States, 91206 | |
| Neurocrine Clinical Site | Recruiting |
| Long Beach, California, United States, 90807 | |
| Neurocrine Clinical Site | Recruiting |
| Oceanside, California, United States, 92056 | |
| Neurocrine Clinical Site | Recruiting |
| Pico Rivera, California, United States, 90660 | |
| Neurocrine Clinical Site | Recruiting |
| Riverside, California, United States, 92506 | |
| Neurocrine Clinical Site | Recruiting |
| San Diego, California, United States, 92102 | |
| Neurocrine Clinical Site | Recruiting |
| San Diego, California, United States, 92103 | |
| Neurocrine Clinical Site | Recruiting |
| San Rafael, California, United States, 94901 | |
| Neurocrine Clinical Site | Recruiting |
| Santa Ana, California, United States, 92705 | |
| Neurocrine Clinical Site | Recruiting |
| Torrance, California, United States, 90502 | |
| United States, Florida | |
| Neurocrine Clinical Site | Recruiting |
| Miami, Florida, United States, 33016 | |
| Neurocrine Clinical Site | Recruiting |
| Miami, Florida, United States, 33133 | |
| Neurocrine Clinical Site | Recruiting |
| Miami, Florida, United States, 33137 | |
| Neurocrine Clinical Site | Recruiting |
| Okeechobee, Florida, United States, 34972 | |
| United States, Georgia | |
| Neurocrine Clinical Site | Recruiting |
| Atlanta, Georgia, United States, 30338 | |
| United States, Illinois | |
| Neurocrine Clinical Site | Recruiting |
| Chicago, Illinois, United States, 60640 | |
| United States, Massachusetts | |
| Neurocrine Clinical Site | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Mississippi | |
| Neurocrine Clinical Site | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Neurocrine Clinical Site | Recruiting |
| Saint Louis, Missouri, United States, 63125 | |
| Neurocrine Clinical Site | Recruiting |
| Saint Louis, Missouri, United States, 63128 | |
| United States, New York | |
| Neurocrine Clinical Site | Recruiting |
| Cedarhurst, New York, United States, 11516 | |
| Neurocrine Clinical Site | Recruiting |
| New York, New York, United States, 10027 | |
| Neurocrine Clinical Site | Recruiting |
| New York, New York, United States, 10032 | |
| United States, Texas | |
| Neurocrine Clinical Site | Recruiting |
| DeSoto, Texas, United States, 75115 | |
| Neurocrine Clinical Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Bulgaria | |
| Neurocrine Clinical Site | Recruiting |
| Pleven, Bulgaria, 5800 | |
| Neurocrine Clinical Site | Recruiting |
| Plovdiv, Bulgaria, 4004 | |
| Neurocrine Clinical Site | Recruiting |
| Sofia, Bulgaria, 1000 | |
| Neurocrine Clinical Site | Recruiting |
| Sofia, Bulgaria, 1113 | |
| Neurocrine Clinical Site | Recruiting |
| Sofia, Bulgaria, 1408 | |
| Neurocrine Clinical Site | Recruiting |
| Sofia, Bulgaria, 1510 | |
| Neurocrine Clinical Site | Recruiting |
| Sofia, Bulgaria, 1680 | |
| Neurocrine Clinical Site | Recruiting |
| Vratsa, Bulgaria, 3000 | |
| Serbia | |
| Neurocrine Clinical Site | Recruiting |
| Belgrade, Serbia, 11000 | |
| Neurocrine Clinical Site | Recruiting |
| Gornja Toponica, Serbia, 18202 | |
| Neurocrine Clinical Site | Recruiting |
| Kragujevac, Serbia, 34000 | |
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
| Study Director: | Clinical Development Lead | Neurocrine Biosciences |
| Responsible Party: | Neurocrine Biosciences |
| ClinicalTrials.gov Identifier: | NCT05182476 |
| Other Study ID Numbers: |
NBI-1065844-CIAS2023 2021-003834-34 ( EudraCT Number ) |
| First Posted: | January 10, 2022 Key Record Dates |
| Last Update Posted: | January 23, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Neurocrine Biosciences:
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Schizophrenia Cognitive Impairment Luvadaxistat NBI-1065844 TAK-831 |
CIAS BAC ERUDITE Neurocrine |
Additional relevant MeSH terms:
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Schizophrenia Cognitive Dysfunction Schizophrenia Spectrum and Other Psychotic Disorders |
Mental Disorders Cognition Disorders Neurocognitive Disorders |