Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeurocrine Biosciences
About this trial
The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria.
Participant had the initial diagnosis of schizophrenia ≥1 year before screening.
Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.
Disqualifiers
Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological [including dementing illness, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1.
Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease.
Participant has a history of clozapine treatment for treatment-resistant psychosis.
Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening.
Trial design
Design model
Parallel
Treatments tested in this trial
NBI-1117568
DrugOral capsules
Placebo
DrugOral capsules
Treatment groups
560 Participants
are divided into 2 treatment groupsGroup A: NBI-1117568Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Time From Randomization to Relapse
Time frame
Up to approximately 30 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov