At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 256 enrolled
Drug / intervention
Luvadaxistat +1 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 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Subjects With Negative Symptoms of Schizophrenia
In Brief
A Phase 2 clinical trial evaluating Luvadaxistat and Placebo for Schizophrenia. Completed, enrolled 256 participants across 54 sites in 8 countries.
Detailed Summary
The purpose of this study is to determine whether add-on luvadaxistat is superior to placebo on the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Czechia, Germany, Italy, Poland, Spain, Ukraine, United States
CollaboratorsTakeda
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartJan 2018
Primary CompletionDec 2020
Study CompletionJan 2021
TodayJul 2026
First PostedDec 26, 2017
Enrollment StartJan 4, 2018
Primary CompletionDec 29, 2020
Study CompletionJan 12, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.5 years ago
Interventions
Luvadaxistatdrug
TAK-831 tablets.
Placebodrug
Luvadaxistat placebo-matching tablets.