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Trial record 2 of 15 for:    avp-786

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 : January 27, 2020
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

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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.


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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
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Contact: Jurandir Araujo 949-268-5770 jaraujo@avanir.com
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com

Locations
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United States, Arkansas
Clinical Research Site Recruiting
Little Rock, Arkansas, United States, 72209
United States, California
Clinical Research Site Recruiting
Anaheim, California, United States, 92805
Clinical Research Site Recruiting
Bellflower, California, United States, 90706
Clinical Research Site Recruiting
Culver City, California, United States, 90230
Clinical Research Site Recruiting
Garden Grove, California, United States, 92845
Clinical Research Site Recruiting
Glendale, California, United States, 91206
Clinical Research Site Recruiting
Lemon Grove, California, United States, 91945
Clinical Research Site Recruiting
Oakland, California, United States, 94607
Clinical Research Site Recruiting
Oceanside, California, United States, 92056
Clinical Research Site Recruiting
Panorama City, California, United States, 91402
Clinical Research Site Recruiting
Riverside, California, United States, 92506
Clinical Research Site Recruiting
San Diego, California, United States, 92102
Clinical Research Site Recruiting
Torrance, California, United States, 90502
United States, Florida
Clinical Research Site Recruiting
Hollywood, Florida, United States, 33021
Clinical Research Site Recruiting
Largo, Florida, United States, 33770
Clinical Research Site Recruiting
Miami, Florida, United States, 33122
Clinical Research Site Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Clinical Research Site Recruiting
Atlanta, Georgia, United States, 30328
United States, Illinois
Clinical Research Site Recruiting
Chicago, Illinois, United States, 60640
United States, Louisiana
Clinical Research Site Recruiting
Lake Charles, Louisiana, United States, 70629
United States, Massachusetts
Clinical Research Site Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, Missouri
Clinical Research Site Recruiting
Olivette, Missouri, United States, 63132
Clinical Research Site 1 Recruiting
Saint Charles, Missouri, United States, 63304
Clinical Research Site 2 Recruiting
Saint Charles, Missouri, United States, 63304
Clinical Research Site Recruiting
Saint Louis, Missouri, United States, 63118
United States, New Jersey
Clinical Research Site Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
Clinical Research Site Recruiting
Jamaica, New York, United States, 11432
Clinical Research Site Withdrawn
New York, New York, United States, 10016
Clinical Research Site Recruiting
Rochester, New York, United States, 14618
United States, Ohio
Clinical Research Site Recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Clinical Research Site Recruiting
Edmond, Oklahoma, United States, 73013
United States, Pennsylvania
Clinical Research Site Recruiting
Norristown, Pennsylvania, United States, 19401
United States, Tennessee
Clinical Research Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Clinical Research Site Recruiting
Richardson, Texas, United States, 75080
Clinical Research Site Recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Clinical Research Site Recruiting
Everett, Washington, United States, 98201
Sponsors and Collaborators
Avanir Pharmaceuticals

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Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03896945    
Other Study ID Numbers: 18-AVP-786-207
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders