Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04512066 · ClinicalTrials.gov registry record · Phase 2
A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 287
- Enrollment target
NCT04512066: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT04512066 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 287 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (116% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04512066, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 287 participants
- Enrollment target
Study 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.
Primary Outcome
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The
Interventions
- DRUG Placebo
- DRUG Risperidone
- DRUG RO6889450
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2020-09-08 |
| Est. Completion | 2022-06-21 |
| Phase | Phase 2 |
What the finished NCT04512066 record still lists
NCT04512066 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (116% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04512066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04512066 about?
NCT04512066 is a clinical study titled "A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder". 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.
What is the current status of trial NCT04512066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 287 participants. The study started on 2020-09-08. Estimated completion is 2022-06-21.
What interventions are being tested in trial NCT04512066?
The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG), RO6889450 (DRUG).
Who is sponsoring clinical trial NCT04512066?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04512066's enrollment target sits among peer trials
287 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03094429 · 287 participants · Phase 2
An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
- NCT06385080 · 287 participants · Phase 1
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
- NCT06919224 · 287 participants · NA
Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease
- NCT02098265 · 288 participants · NA
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI