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A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669640
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.

Condition or disease Intervention/treatment Phase
Schizophrenia, Schizoaffective Disorder Drug: RO6889450 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : December 24, 2022
Estimated Study Completion Date : December 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Part A: Monotherapy
Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment.
Drug: RO6889450
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.

Drug: Placebo
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.

Experimental: Part B: Add-On Therapy
Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).
Drug: RO6889450
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.

Drug: Placebo
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.




Primary Outcome Measures :
  1. Change from Baseline at Week 12 in Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in Clinical Global Impression Severity (CGI-S) Overall Scores [ Time Frame: Baseline to week 12 ]
  2. Change from Baseline in CGI-S Negative Symptoms Scores [ Time Frame: Baseline to week 12 ]
  3. Clinical Global Impression - Improvement (CGI-I) Overall Scores [ Time Frame: Week 12 ]
  4. CGI-I Negative Symptoms Scores [ Time Frame: Week 12 ]
  5. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores [ Time Frame: Baseline to week 12 ]
  6. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Symptom Factor Scores [ Time Frame: Baseline to week 12 ]
  7. Change from Baseline in Brief Negative Symptom Scale (BNSS) Total Scores [ Time Frame: Baseline to week 12 ]
  8. Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores [ Time Frame: Baseline to week 12 ]
  9. Change from Baseline in Defeatist Performance Attitude Scale (DPAS) Scores [ Time Frame: Baseline to week 12 ]
  10. Percentage of Participants with Adverse Events (AE) [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
  11. Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Scores [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
  12. Change from Baseline in Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A) [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
  13. Area Under the Curve at Steady State (AUCss) of RO6889450 [ Time Frame: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks) ]
  14. Maximum Serum Concentration (Cmax) of RO6889450 [ Time Frame: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
  • Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonists, or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics
  • Medically stable during the 3 months prior to study entry
  • Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months
  • PANSS negative symptom factor score of 18 or higher
  • The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control)
  • Has an informant who is considered reliable by the Investigator
  • Body mass index (BMI) between 18-35 kg/m2 inclusive
  • Female participants are eligible to participate if not pregnant, not breastfeeding and agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug

Exclusion Criteria:

  • Moderate to severe substance use disorder within six months of study entry (excluding nicotine or caffeine) as defined by DSM-5
  • Extrapyramidal symptom rating scale (ESRS) total score greater than or equal to 3
  • Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
  • PANSS item G6 (depression) greater than or equal to 5
  • Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment
  • A prior or current general medical condition that might be impairing cognition or other psychiatric functioning
  • Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-2. HCV antibody positive participants are eligible if HCV RNA is negative
  • Tardive dyskinesia that is moderate to severe or requires treatment
  • History of neuroleptic malignant syndrome
  • Average triplicate Fridericia's Correction Formula (QTcF) interval greater than 450 milliseconds (msec) for males and 470 msec for females or other clinically significant abnormality on screening electrocardiogram (ECG) based on centralized reading
  • Clinically significant abnormalities in laboratory safety test results
  • Significant or unstable physical condition that in the investigator's judgment might require a change in medication or hospitalization during the course of the study
  • On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening
  • Any history of clozapine treatment
  • History of treatment with electroconvulsive therapy (ECT)
  • Concomitant use of prohibited medications
  • Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates
  • Receipt of an investigational drug within 28 days or five times the half-life of the investigational drug (whichever is longer) before the first study drug administration
  • Donation of blood over 400 mL within 3 months prior to screening
  • Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to Investigator and/or institutional approval to enroll

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669640


Contacts
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Contact: Reference Study ID Number: BP40283 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03669640    
Other Study ID Numbers: BP40283
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders