A multicenter, randomized, double-blind, placebo-controlled, parallel-arm study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of negative symptoms of schizophrenia

  • STATUS
    Recruiting
  • End date
    Jan 31, 2022
  • sponsor
    Avanir Pharmaceuticals, Inc.
Updated on 5 April 2021

Summary

The purpose of this research is to evaluate the efficacy, safety and tolerability of AVP-786 compared to placebo for the treatment of negative symptoms of schizophrenia. Negative symptoms of schizophrenia can include difficulty in displaying emotion through facial expressions, apathy (lack of interest), slowed speech production, loss of ability to anticipate or experience joy or pleasure, loss of motivation, and reduced social drive or interest.

AVP-786 is targeted to treat negative symptoms. About 370 participants and approximately 50 study centers in the United States will participate in this study. Participation in this study will last approximately 23 weeks (including screening and follow-up). AVP-786 is being developed by Avanir Pharmaceuticals, Inc. This is a research study to test an investigational drug. An investigational drug is one that is not approved by the Food and Drug Administration (FDA). The investigational drug, AVP-786, will be compared to placebo.

Description

Sponsor: Avanir Pharmaceuticals, Inc.
Indication: Negative Symptoms of Schizophrenia
Study Drug: AVP-786
Study Phase: 2/3

  • Screening period – up to 28 days (+14 day extension with med mon approval) – 1 visit
  • Double-Blind Treatment period – 15 weeks – 6 visits, 5 phone calls
  • Safety follow up period – 30 days – 1 phone call
50% AVP-786 - 50% Placebo

Details
Condition Schizophrenia and Schizoaffective Disorders
Clinical Study IdentifierTX270525
SponsorAvanir Pharmaceuticals, Inc.
Last Modified on5 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females 18 to 60 years of age who meet DSM-5 criteria for schizophrenia onset at least 1 year and have been clinically stable for at least 6 months (no psychiatric hospital admissions or acute exacerbations)
Stable living situation for at least 30 days before screening
Patients should be treated with a second-generation atypical antipsychotic drug (SGA) other than clozapine in any approved dosage form for at least 3 months prior to screening and be on a stable dose for at least 30 days and may not be treated with more than one SGA with the exception of low dose quetiapine (up to 50 mg at night) for insomnia
Negative symptoms that have been present for at least 6 months, in the judgment of the Investigator
Patients must have a reliable informant (e.g., case manager, social worker, family member). In the opinion of the Investigator, the informant should spend an adequate amount of time with the patient to be able to address behaviors, activities and symptoms. The Investigator (or designee) should address this relationship in their initial assessment of the patient (or during the screening period). Must be in person at screening, phone calls rest of study

Exclusion Criteria

Patients who have been hospitalized within the last 6 months before screening for social reasons will be allowed upon consultation with the Medical Monitor, but currently hospitalized patients will be excluded
Current major depressive disorder (MDD), a diagnosis of schizoaffective disorder or bipolar disorder
Patients with pseudo-parkinsonism secondary to their ongoing antipsychotic medication based on Investigator judgment
Current clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders, such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not expose the patient to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy
Patients who test positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
Known hypersensitivity to DM, d6-DM, Q, opiate drugs (codeine, etc.), or any other ingredient of the study medication
Patients who have received DM co-administered with Q within 3 months prior to Visit 1
Patients who have ever received d6-DM co-administered with Q, or were enrolled in Study 15-AVP-786-202
Myasthenia gravis (a contraindication for Q)
Patients with a history of substance and/or alcohol abuse within 6 months prior to Screening. All tobacco and nicotine products are allowed
Patients who are found to be a “Virtually Certain” match in the Clinical Trial Subject Database (CTSdatabase) with a patient who has participated in another interventional drug or device study within 30 days prior to Visit 1
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