At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 287 enrolled
Drug / intervention
RO6889450 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
In Brief
A Phase 2 clinical trial evaluating RO6889450, Placebo, and 1 other intervention for Schizophrenia, Schizoaffective Disorder. Completed, enrolled 287 participants across 40 sites in 4 countries.
Detailed Summary
This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesJapan, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartSep 2020
Primary CompletionJun 2022
TodayJul 2026
First PostedAug 13, 2020
Enrollment StartSep 8, 2020
Primary CompletionJun 21, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.9 years ago
Interventions
RO6889450drug
Participants will receive oral RO6889450 QD.
Placebodrug
Participants will receive oral placebo QD.
Risperidonedrug
Participants will receive oral risperidone QD.