A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
NCT ID: NCT03745820
Last Updated: 2023-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2018-11-15
2022-04-07
Brief Summary
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The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BIIB104 0.5 mg
Participants will receive 0.5 mg of BIIB104 twice a day, orally, for 12 weeks.
BIIB104
Administered as specified in the treatment arm
BIIB104 0.15 mg
Participants will receive 0.15 mg of BIIB104 twice a day, orally, for 12 weeks.
BIIB104
Administered as specified in the treatment arm
Matching Placebo
Participants will receive matching placebo twice a day, orally, for 12 weeks.
Placebo
Administered as specified in the treatment arm
Interventions
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BIIB104
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of stable schizophrenia symptomatology ≥12 weeks (e.g., no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of schizophrenia symptoms).
* Participants must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for ≥8 weeks prior to Baseline/Day 1, including concomitant psychotropic medication. Doses of background atypical antipsychotics should be within the recommended dose range listed in the approved product labeling of the country where the study is being conducted.
* SCI-PANSS: No more than moderate-severe rating (score ≤5) on delusions, hallucinatory behavior, grandiosity, suspiciousness / persecution, and hostility (i.e. PANSS, positive symptom items P1, P3, P5, P6, P7); or unusual thought content (G9); and no more than a moderate rating (score ≤4) on conceptual disorganization (P2).
Exclusion Criteria
* Participation in cognitive remediation therapy within 6 months prior to randomization.
* Screening MCCB Working Memory Domain T-score ≥60.
* Current DSM-5 diagnosis of schizoaffective disorder on the MINI 7.0.2 for Psychotic Disorders.
* Current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and/or generalized anxiety disorder on the MINI 7.0.2 for Psychotic Disorders.
* Lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, and/or binge-eating disorder on the MINI 7.0.2 for Psychotic Disorders.
* Meets the DSM-5 diagnosis of moderate or severe substance use disorder (excluding nicotine dependence) within 12 months of screening on the MINI 7.0.2 for Psychotic Disorders interview.
* DSM-5 diagnosis of Intellectual Disability (intellectual developmental disorder).
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Pillar Clinical Research, LLC
Bentonville, Arkansas, United States
ProScience Research Group
Culver City, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Synergy San Diego
Lemon Grove, California, United States
Research Site
Long Beach, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Excell Research
Oceanside, California, United States
Research Site
Pico Rivera, California, United States
CNRI - San Diego, LLC
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
San Rafael, California, United States
Research Site
Torrance, California, United States
Yale University, Department of Psychiatry
New Haven, Connecticut, United States
Research Site
Lauderhill, Florida, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Research Site
Decatur, Georgia, United States
Research Site
Chicago, Illinois, United States
Alexian Brothers Hospital Network
Hoffman Estates, Illinois, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, United States
Research Site
Gaithersburg, Maryland, United States
Cherry Health
Grand Rapids, Michigan, United States
Research Site
Flowood, Mississippi, United States
Research Site
St Louis, Missouri, United States
St. Louis Clinical Trials, LC
St Louis, Missouri, United States
Hassman Research Institute
Berlin, New Jersey, United States
UB Department Psychiatry
Buffalo, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
The Ohio State University Department of Psychiatry
Columbus, Ohio, United States
Research Site
North Canton, Ohio, United States
Research Site
Richardson, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Research Site
Kirkland, Washington, United States
Zentrum für klinische Forschung Dr. med. I. Schöll
Bad Homburg, Hesse, Germany
Clinic for Psychiatrie
Frankfurt am Main, Hesse, Germany
Universitätsmedizin Göttingen, Klinik für Psychiatrie und Psychotherapie
Westerstede, Lower Saxony, Germany
Dpt of Psychiatry and Psychotherapy, University of Leipzig
Leipzig, Saxony, Germany
Research Site
Anan-shi, , Japan
Research Site
Ichikawa-shi, , Japan
Research Site
Kashihara-shi, , Japan
Research Site
Kawasaki-shi, , Japan
Research Site
Kita-gun, , Japan
Research Site
Kodaira-shi, , Japan
Research Site
Kumagaya-shi, , Japan
Research Site
Takasaki-shi, , Japan
Research Site
Yokosuka-shi, , Japan
Hospital Universitario Marques Valdecilla
Santander, Cantabria, Spain
Research Site
Majadahonda, Madrid, Spain
Research Site
Oviedo, Principality of Asturias, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Unidad Neurociencias CS San Juan
Salamanca, , Spain
Research Site
Seville, , Spain
Oxford Health NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
Abraham Cowley Unit
Lyne, Surrey, United Kingdom
Research Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003825-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
263CS201
Identifier Type: -
Identifier Source: org_study_id
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