Trial · NCT04512066
A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
NCT04512066, Phase 2, Completed, Hoffmann-La Roche; results first posted 2023-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder. Trials, record NCT04512066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04512066
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
- NCT number
- NCT04512066
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 287 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- RO6889450, Placebo, Risperidone
- First posted
- 2020-08-13
- Last updated
- 2023-10-10
- Results first posted
- 2023-10-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Week 4 (Day 28) | 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 General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity. |
| Secondary | Change From Baseline in PANSS Factor Scores at Week 4 | Week 4 (Day 28) | PANSS factors are modified groupings of the 30 PANSS items from the original three subscales (positive, negative, and general psychopathology). Each item is rated on a scale of 1 (absent) to 7 (most extreme). The positive symptom factor contains 8 items (score range 8-56); the negative symptom and disorganized thought/cognition factors contain 7 items (score range 7-49); the uncontrolled hostility/excitement, expressive deficit, and anxiety/depression factors contain 4 items (score range 4-28); and the avolition domain contains 3 items (score range 3-21). The negative and positive totals each have a range of 7-49 and the general total has a range of 16-112. Higher scores indicate higher symptom severity. |
| Secondary | Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score | Baseline to Week 12 | 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 General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity. |
| Secondary | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 4 (Day 28) | The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms. |
| Secondary | Clinical Global Impression - Improvement (CGI-I) Scores | Week 4 (Day 28) | The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse. |
| Secondary | PANSS Total Score at Week 12 | Week 12 | 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 General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity. |
| Secondary | Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12 | Weeks 4, 8, and 12 | 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 General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity. |
| Secondary | CGI-S up to Week 12 | Up to Week 12 | The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms. |
| Secondary | CGI-I up to Week 12 | Up to Week 12 | The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse. |
| Secondary | Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment | after 4-week treatment | The RDQ is a tool used to assess inpatients with schizophrenia on their readiness for discharge from inpatient treatment. It consists of five items that assess suicidality/homicidality, control of aggression/impulsivity, activities of daily living, medication-taking, and delusions/hallucinations interfering with functioning and global status. An additional item examines the overall clinical state of the patient and the final question assesses readiness for discharge. The values reported are the proportion (expressed as a percentage) of participants in each analysis group considered ready for discharge according to the RDQ. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Week 4 (Day 28) | The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in PANSS Factor Scores at Week 4 | Week 4 (Day 28) | The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Units on a scale | MEAN |
| SECONDARY | Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score | Baseline to Week 12 | The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Proportion expressed as percentage | NUMBER |
| SECONDARY | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Week 4 (Day 28) | The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Units on a scale | MEAN |
| SECONDARY | Clinical Global Impression - Improvement (CGI-I) Scores | Week 4 (Day 28) | The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Units on a scale | MEAN |
| SECONDARY | PANSS Total Score at Week 12 | Week 12 | The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Units on a scale | MEAN |
| SECONDARY | Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12 | Weeks 4, 8, and 12 | The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Proportion expressed as a percentage | NUMBER |
| SECONDARY | CGI-S up to Week 12 | Up to Week 12 | The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Units on a scale | MEAN |
| SECONDARY | CGI-I up to Week 12 | Up to Week 12 | The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Units on a scale | MEAN |
| SECONDARY | Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment | after 4-week treatment | The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline. | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group217
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Placebo | Baseline | 99.38 | Standard Deviation 11.36 | Units on a scale |
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | RO6889450 45 mg | Baseline | 98.54 | Standard Deviation 9.51 | Units on a scale |
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | RO6889450 150 mg | Baseline | 100.53 | Standard Deviation 12.25 | Units on a scale |
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Risperidone 4 mg | Baseline | 100.03 | Standard Deviation 10.56 | Units on a scale |
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Placebo | Day 28 | 88.69 | Standard Deviation 20.18 | Units on a scale |
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | RO6889450 45 mg | Day 28 | 88.94 | Standard Deviation 17.03 | Units on a scale |
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | RO6889450 150 mg | Day 28 | 85.18 | Standard Deviation 17.67 | Units on a scale |
| Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Risperidone 4 mg | Day 28 | 78.04 | Standard Deviation 15.78 | Units on a scale |
| Change From Baseline in PANSS Factor Scores at Week 4 | Placebo | Anxiety/Depression - Baseline | 11.58 | Standard Deviation 3.39 | Units on a scale |
| Change From Baseline in PANSS Factor Scores at Week 4 | RO6889450 45 mg | Anxiety/Depression - Baseline | 12.91 | Standard Deviation 2.92 | Units on a scale |
1 to 10 of 217Source ClinicalTrials.gov
See all 217 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Placebo | 73 | |
| Double-blind Treatment Period | STARTED | RO6889450 45 mg | 71 | |
| Double-blind Treatment Period | STARTED | RO6889450 150 mg | 69 | |
| Double-blind Treatment Period | STARTED | Risperidone 4 mg | 74 | |
| Double-blind Treatment Period | STARTED | Placebo - RO6889450 45 mg | 0 | |
| Double-blind Treatment Period | STARTED | Placebo - RO6889450 150 mg | 0 | |
| Double-blind Treatment Period | COMPLETED | Placebo | 56 | |
| Double-blind Treatment Period | COMPLETED | RO6889450 45 mg | 55 | |
| Double-blind Treatment Period | COMPLETED | RO6889450 150 mg | 53 | |
| Double-blind Treatment Period | COMPLETED | Risperidone 4 mg | 60 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events117
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anxiety | Psychiatric disorders | Placebo | 6 | 72 | |
| other | Anxiety | Psychiatric disorders | RO6889450 45 mg (Double-blind Treatment Period) | 3 | 65 | |
| other | Anxiety | Psychiatric disorders | RO6889450 150 mg (Double-blind Treatment Period) | 2 | 68 | |
| other | Anxiety | Psychiatric disorders | Risperidone 4 mg (Double-blind Treatment Period) | 5 | 71 | |
| other | Anxiety | Psychiatric disorders | Placebo - RO6889450 45 mg | 0 | 25 | |
| other | Anxiety | Psychiatric disorders | Placebo - RO6889450 150 mg | 0 | 25 | |
| other | Anxiety | Psychiatric disorders | RO6889450 45 mg (Extension Period) | 0 | 41 | |
| other | Anxiety | Psychiatric disorders | RO6889450 150 mg (Extension Period) | 1 | 45 | |
| other | Anxiety | Psychiatric disorders | Risperidone 4 mg (Extension Period) | 0 | 53 | |
| other | Insomnia | Psychiatric disorders | Placebo | 1 | 72 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 72 |
| Total, all-cause mortality | RO6889450 45 mg (Double-blind Treatment Period) | 0 | 65 |
| Total, all-cause mortality | RO6889450 150 mg (Double-blind Treatment Period) | 0 | 68 |
| Total, all-cause mortality | Risperidone 4 mg (Double-blind Treatment Period) | 0 | 71 |
| Total, all-cause mortality | Placebo - RO6889450 45 mg | 0 | 25 |
| Total, all-cause mortality | Placebo - RO6889450 150 mg | 1 | 25 |
| Total, all-cause mortality | RO6889450 45 mg (Extension Period) | 0 | 41 |
| Total, all-cause mortality | RO6889450 150 mg (Extension Period) | 0 | 45 |
| Total, all-cause mortality | Risperidone 4 mg (Extension Period) | 0 | 53 |
| Total, other adverse events | Placebo | 23 | 72 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36369028 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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