A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)

NCT03745820 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 263CS2012018-003825-27
• Study Type: interventional
• Target: 195
• Locations: 5 countries
• Sites: 60

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.

Conditions

Cognitive Impairment Associated With Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

  The MCCB is a cognitive battery that assesses 7 domains recommended by the MATRICS initiative (i.e., Working Memory, Verbal Learning, Speed of Processing, Attention/Vigilance, Visual Learning, Social Cognition, and Reasoning and Problem Solving). MCCB was administered via laptop computer and paper-and-pencil assessments. T-scores for the individual tests were calculated according to the developer's recommended scoring algorithms. MCCB composite T scores are between 40 and 60 (normal range). Higher scores indicate better cognitive functioning. The working memory domain score of the MCCB is reported in this outcome measure.

  Baseline and Week 12

Secondary Outcomes (10)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From first dose of study drug through end of the study (up to Week 14)

• Mean Total Score Assessed by Scale for the Assessment and Rating of Ataxia (SARA)

  Baseline, Weeks 2, 6, 12 and safety follow-up (Week 14)

• 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

  Up to Week 14

• Change From Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment at Week 12

  Baseline and Week 12

• Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Assessment Score at Week 12

  Baseline and Week 12

Study Arms (3)

BIIB104 0.5 mg

EXPERIMENTAL

Participants will receive 0.5 mg of BIIB104 twice a day, orally, for 12 weeks.

Drug: BIIB104

BIIB104 0.15 mg

EXPERIMENTAL

Participants will receive 0.15 mg of BIIB104 twice a day, orally, for 12 weeks.

Drug: BIIB104

Matching Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo twice a day, orally, for 12 weeks.

Other: Placebo

Interventions

BIIB104 DRUG

Administered as specified in the treatment arm

Also known as: PF-04958242

BIIB104 0.15 mg; BIIB104 0.5 mg

Placebo OTHER

Administered as specified in the treatment arm

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biogen: lead

Study Sites (60)

Pillar Clinical Research, LLC

Bentonville, Arkansas, 72712, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Research Site

Long Beach, California, 90807, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

Research Site

Pico Rivera, California, 90660, United States

Location

CNRI - San Diego, LLC

San Diego, California, 92102, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Research Site

San Diego, California, 92123, United States

Location

Research Site

San Rafael, California, 94901, United States

Location

Research Site

Torrance, California, 90502, United States

Location

Yale University, Department of Psychiatry

New Haven, Connecticut, 06519, United States

Location

Research Site

Lauderhill, Florida, 33319, United States

Location

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Research Site

Decatur, Georgia, 30030, United States

Location

Research Site

Chicago, Illinois, 60611, United States

Location

Alexian Brothers Hospital Network

Hoffman Estates, Illinois, 60169, United States

Location

Southern Illinois University, School of Medicine

Springfield, Illinois, 62702, United States

Location

Research Site

Gaithersburg, Maryland, 20877, United States

Location

Cherry Health

Grand Rapids, Michigan, 49503, United States

Location

Research Site

Flowood, Mississippi, 39232, United States

Location

Research Site

St Louis, Missouri, 63128, United States

Location

St. Louis Clinical Trials, LC

St Louis, Missouri, 63141, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

UB Department Psychiatry

Buffalo, New York, 104051, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

The Ohio State University Department of Psychiatry

Columbus, Ohio, 43210, United States

Location

Research Site

North Canton, Ohio, 44720, United States

Location

Research Site

Richardson, Texas, 75080, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

Research Site

Kirkland, Washington, 98033, United States

Location

Zentrum für klinische Forschung Dr. med. I. Schöll

Bad Homburg, Hesse, 61348, Germany

Location

Clinic for Psychiatrie

Frankfurt am Main, Hesse, 60528, Germany

Location

Universitätsmedizin Göttingen, Klinik für Psychiatrie und Psychotherapie

Westerstede, Lower Saxony, 26655, Germany

Location

Dpt of Psychiatry and Psychotherapy, University of Leipzig

Leipzig, Saxony, 04103, Germany

Location

Research Site

Anan-shi, Japan

Location

Research Site

Ichikawa-shi, Japan

Location

Research Site

Kashihara-shi, Japan

Location

Research Site

Kawasaki-shi, Japan

Location

Research Site

Kita-gun, Japan

Location

Research Site

Kodaira-shi, Japan

Location

Research Site

Kumagaya-shi, Japan

Location

Research Site

Takasaki-shi, Japan

Location

Research Site

Yokosuka-shi, Japan

Location

Hospital Universitario Marques Valdecilla

Santander, Cantabria, 39008, Spain

Location

Research Site

Majadahonda, Madrid, 28222, Spain

Location

Research Site

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28040, Spain

Location

Unidad Neurociencias CS San Juan

Salamanca, 37005, Spain

Location

Research Site

Seville, 41013, Spain

Location

Oxford Health NHS Foundation Trust

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Abraham Cowley Unit

Lyne, Surrey, KT16 0AE, United Kingdom

Location

Research Site

London, SE5 8AZ, United Kingdom

Location

MeSH Terms

Interventions

PF-04958242

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: November 15, 2018
• Primary Completion: March 23, 2022
• Study Completion: April 7, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Locations

ES (7); US (37); JP (9); DE (4); GB (3)