Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

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: NCT03896945
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: AVP-786 Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules will be administered orally twice a day over a 15-week period.
Drug: Placebo
oral capsules

Experimental: AVP-786
AVP-786 capsules will be administered orally twice a day over a 15-week period.
Drug: AVP-786
oral capsules




Primary Outcome Measures :
  1. Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score [ Time Frame: Baseline; Week 15 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score [ Time Frame: Baseline; Week 15 ]
  2. Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline; Week 15 ]
  3. Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score [ Time Frame: Baseline; Week 15 ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2
  • Participants must meet Positive and Negative Syndrome Scale (PANSS) criteria
  • Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible provided they are on a stable dose

Exclusion Criteria:

  • Participants with current major depressive disorder (MDD)
  • Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
  • Participants currently using anticholinergic medications
  • Participants recently hospitalized as in-patients

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): NCT03896945


Contacts
Layout table for location contacts
Contact: Sophie Guillaume 949-643-6877 sguillaume@avanir.com
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com

  Show 36 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals

Layout table for additonal information
Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03896945     History of Changes
Other Study ID Numbers: 18-AVP-786-207
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Avanir Pharmaceuticals:
Negative Symptoms
Schizophrenia
AVP-786
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders