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
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.
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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