Clinical trial NCT03745820: A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
Official title: A Phase 2, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIIB104 in Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Impairment Associated With Schizophrenia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-11-19
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).

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.


Eligibility criteria: Key Inclusion Criteria:

* Otherwise healthy participant with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), diagnosis of schizophrenia of at least 2 years' duration as confirmed by the mini-international neuropsychiatric interview (MINI) 7.0.2 for Psychotic Disorders.
* 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).

Key Exclusion Criteria:

* Participation in a trial using any component or version of the MATRICS Consensus Cognitive Battery (MCCB) or the University of California, San Diego (UCSD) Performance-Based Skills Assessment test within the previous 6 months.
* 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).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Working Memory Domain Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug through end of the study (up to Week 14)
measure: Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14)
measure: Number of Participants With at Least One Event of Suicidal Ideation and/or Suicidal Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to Week 14
measure: Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Pillar Clinical Research, LLC
state: Arkansas
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Pico Rivera
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: CNRI - San Diego, LLC
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Rafael
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Yale University, Department of Psychiatry
state: Connecticut
city: Lauderhill
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University, School of Medicine
state: Illinois
city: Gaithersburg
country: United States
facility: Research Site
state: Maryland
city: Grand Rapids
country: United States
facility: Cherry Health
state: Michigan
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials, LC
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Buffalo
country: United States
facility: UB Department Psychiatry
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Columbus
country: United States
facility: The Ohio State University Department of Psychiatry
state: Ohio
city: North Canton
country: United States
facility: Research Site
state: Ohio
city: Richardson
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Bad Homburg
country: Germany
facility: Zentrum für klinische Forschung Dr. med. I. Schöll
state: Hessen
city: Frankfurt
country: Germany
facility: Clinic for Psychiatrie
state: Hessen
city: Westerstede
country: Germany
facility: Universitätsmedizin Göttingen, Klinik für Psychiatrie und Psychotherapie
state: Niedersachsen
city: Leipzig
country: Germany
facility: Dpt of Psychiatry and Psychotherapy, University of Leipzig
state: Sachsen
city: Anan-shi
country: Japan
facility: Research Site
city: Ichikawa-shi
country: Japan
facility: Research Site
city: Kashihara-shi
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Kita-gun
country: Japan
facility: Research Site
city: Kodaira-shi
country: Japan
facility: Research Site
city: Kumagaya-shi
country: Japan
facility: Research Site
city: Takasaki-shi
country: Japan
facility: Research Site
city: Yokosuka-shi
country: Japan
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Salamanca
country: Spain
facility: Unidad Neurociencias CS San Juan
city: Sevilla
country: Spain
facility: Research Site
city: Oxford
country: United Kingdom
facility: Oxford Health NHS Foundation Trust
state: Oxfordshire
city: Lyne
country: United Kingdom
facility: Abraham Cowley Unit
state: Surrey
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: