Trial record 4 of 24 for:    avanir

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02477670
First received: June 18, 2015
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.

Condition Intervention Phase
Schizophrenia
Drug: AVP-786
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) as an Adjunctive Treatment for Patients With Residual Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • NSA 16 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    16-Item Negative Symptom Assessment (NSA 16) total score.


Secondary Outcome Measures:
  • PANSS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale total score

  • MCCB [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    MATRICS Consensus Cognitive Battery (MCCB) composite score

  • PGI-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient Global Impression of Change

  • CDSS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Calgary Depression Scale for Schizophrenia


Estimated Enrollment: 120
Study Start Date: September 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo capsules administered twice a day over a 12-week period
Drug: Placebo
Experimental: AVP-786
AVP-786 dose 2 capsules administered twice a day over a 12-week period
Drug: AVP-786

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0.
  • Patients must meet PANSS criteria
  • Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose

Exclusion Criteria:

  • Patients with current major depressive disorder (MDD)
  • Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
  • Patients currently using anticholinergic medications
  • Recent in-patient hospitalization
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02477670

Contacts
Contact: Fred Ledon fledon@avanir.com
Contact: Paul Shin pshin@avanir.com

Locations
United States, California
Recruiting
Cerritos, California, United States
Recruiting
Garden Grove, California, United States
Recruiting
National City, California, United States
Recruiting
Oakland, California, United States
Recruiting
San Diego, California, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Recruiting
Orlando, Florida, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
Recruiting
Augusta, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
Recruiting
Worcester, Massachusetts, United States
United States, Michigan
Recruiting
Grand Rapids, Michigan, United States
United States, New Jersey
Recruiting
Marlton, New Jersey, United States
United States, New York
Recruiting
Jamaica, New York, United States
Recruiting
New York, New York, United States
Recruiting
Rochester, New York, United States
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02477670     History of Changes
Other Study ID Numbers: 15-AVP-786-202 
Study First Received: June 18, 2015
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:
Negative Symptoms
Schizophrenia
AVP-786

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016