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

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ClinicalTrials.gov Identifier: NCT03896945
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 19, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)		 Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score [ Time Frame: Baseline; Week 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score [ Time Frame: Baseline; Week 15 ]
  • Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline; Week 15 ]
  • Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score [ Time Frame: Baseline; Week 15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Placebo
    oral capsules
  • Drug: AVP-786
    oral capsules
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo capsules will be administered orally twice a day over a 15-week period.
    Intervention: Drug: Placebo
  • Experimental: AVP-786
    AVP-786 capsules will be administered orally twice a day over a 15-week period.
    Intervention: Drug: AVP-786
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)		 370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.
  • Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.
  • Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jurandir Araujo 949-268-5770 jaraujo@avanir.com
Contact: Nadine Knowles 949-268-8972 nknowles@avanir.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896945
Other Study ID Numbers  ICMJE 18-AVP-786-207
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Avanir Pharmaceuticals
Study Sponsor  ICMJE Avanir Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avanir Pharmaceuticals
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP