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

Primary Purpose

Cognitive Impairment Associated With Schizophrenia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BIIB104

Placebo

About this trial

This is an interventional treatment trial for Cognitive Impairment Associated With Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pillar Clinical Research, LLC
ProScience Research Group
Collaborative Neuroscience Network, LLC
Synergy San Diego
Research Site
Catalina Research Institute, LLC
Excell Research
Research Site
CNRI - San Diego, LLC
Artemis Institute for Clinical Research
Research Site
Research Site
Research Site
Yale University, Department of Psychiatry
Research Site
Premier Clinical Research Institute, Inc.
Stedman Clinical Trials
Atlanta Center for Medical Research
Augusta University
Research Site
Research Site
Alexian Brothers Hospital Network
Southern Illinois University, School of Medicine
Research Site
Cherry Health
Research Site
Research Site
St. Louis Clinical Trials, LC
Hassman Research Institute
UB Department Psychiatry
Neurobehavioral Research, Inc.
Finger Lakes Clinical Research
The Ohio State University Department of Psychiatry
Research Site
Research Site
The University of Texas Health Science Center at San Antonio
Research Site
Zentrum für klinische Forschung Dr. med. I. Schöll
Clinic for Psychiatrie
Universitätsmedizin Göttingen, Klinik für Psychiatrie und Psychotherapie
Dpt of Psychiatry and Psychotherapy, University of Leipzig
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Hospital Universitario Marques Valdecilla
Research Site
Hospital Clinic de Barcelona
Hospital Universitario 12 de Octubre
Unidad Neurociencias CS San Juan
Research Site
Oxford Health NHS Foundation Trust
Abraham Cowley Unit
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

BIIB104 0.5 mg

BIIB104 0.15 mg

Matching Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.

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

The SARA is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA scale is an eight-item clinical rating scale (gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test) with a total score range of 0-40, where 0 is the best neurological status and 40 is the worst neurological status.

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

The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 6-item scale: 1 (actual attempt), 2 (interrupted attempt), 3 (aborted attempt), 4 (preparatory acts or behavior), 5 (suicidal behavior), and 6 (suicide). The data analyzed signifies the participants with at least one event of suicidal ideation and/or suicidal behavior.

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

The UPSA-Bi, international version, an abbreviated version of the UPSA-Validation of Intermediate Measures, is a measure of functional capacity and assesses skills used in community tasks. This assessment measures 2 general skills that were previously identified as essential to functioning in the community: financial skills and communication skills. The UPSA-Bi assessment is scored from 0-100, higher scores indicating higher functional status.

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

The SCoRS is an interview-based assessment of cognition that involves interviews with participants and informants. The SCoRS includes 20 items designed to specifically assess aspects of cognitive functioning found in each of the seven MCCB cognitive domains including the following: Memory: 4 items; Learning: 2 items; Attention: 3 items; Working memory: 2 items; Problem solving: 3 items; Processing/motor speed: 2 items; Social cognition: 3 items; Language: 1 item. Total score range is 20-80, lower scores indicating higher functional status. The data reported in this outcome measure are for global rating score.

Change From Baseline in MCCB Neurocognitive Composite Scores 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 MCCB composite score contains all of the tests and domains of the MCCB.

Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) 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. All the domain scores of the MCCB are reported in this outcome measure with the exception of working memory domain.

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12

The PANSS includes 3 subscales and 30 items: 7 items that make up the Positive subscale (e.g., delusions, conceptual disorganization, hallucinatory behaviour); 7 items that make up the Negative subscale (e.g., blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology subscale (e.g., somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Each item on the positive, negative and general psychopathology subscale is rated from 1 (absent) to 7 (extreme). The score range is 7-49 for positive and negative subscales, score range is 16-112 for the general psychopathology subscale. Total PANSS score (positive+ negative + general psychopathology subscale scores) range from 30 to 210. Higher scores represent more severity in symptoms.

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12

The CGI-S consists of a single 7-point rating score of illness severity. The following question: "Considering your total clinical experience with this particular population, how mentally ill is your participant at this time?" is rated with a score from 1 to 7- 1: Normal, not ill at all; 2: Borderline mentally ill; 3: Mildly ill; 4: Moderately ill; 5: Markedly ill; 6: Severely ill; or 7: Among the most severely ill participants. Lower scores indicate less severity of illness.

Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12

The CGI-I consists of a single 7-point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. The following question: "Compared to your participant's condition at the beginning of treatment, how much has your participant changed?" is rated with a score from 1 to 7- 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse. Lower scores indicate greater improvement.

Full Information

NCT ID

NCT03745820

First Posted

November 15, 2018

Last Updated

March 23, 2023

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT03745820

Brief Title

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

Acronym

TALLY

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

March 23, 2022 (Actual)

Study Completion Date

April 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment Associated With Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIIB104 0.5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

BIIB104 0.15 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Matching Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BIIB104

Other Intervention Name(s)

PF-04958242

Intervention Description

Administered as specified in the treatment arm

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Administered as specified in the treatment arm

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Up to Week 14

Title

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

Description

Time Frame

Baseline and Week 12

Title

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

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in MCCB Neurocognitive Composite Scores at Week 12

Description

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 MCCB composite score contains all of the tests and domains of the MCCB.

Time Frame

Baseline and Week 12

Title

Change From Baseline in MCCB Individual Domain Scores (Excluding Working Memory Domain) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Subscale, and Negative Subscale Scores at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scores at Week 12

Description

Time Frame

Baseline and Week 12

Title

Number of Participants With Response on Clinical Global Impression-Improvement (CGI-I) Scale at Week 12

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Pillar Clinical Research, LLC

City

Bentonville

State/Province

Arkansas

ZIP/Postal Code

72712

Country

United States

Facility Name

ProScience Research Group

City

Culver City

State/Province

California

ZIP/Postal Code

90230

Country

United States

Facility Name

Collaborative Neuroscience Network, LLC

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Synergy San Diego

City

Lemon Grove

State/Province

California

ZIP/Postal Code

91945

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Catalina Research Institute, LLC

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Excell Research

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Research Site

City

Pico Rivera

State/Province

California

ZIP/Postal Code

90660

Country

United States

Facility Name

CNRI - San Diego, LLC

City

San Diego

State/Province

California

ZIP/Postal Code

92102

Country

United States

Facility Name

Artemis Institute for Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Research Site

City

San Rafael

State/Province

California

ZIP/Postal Code

94901

Country

United States

Facility Name

Research Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Yale University, Department of Psychiatry

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Research Site

City

Lauderhill

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Premier Clinical Research Institute, Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33122

Country

United States

Facility Name

Stedman Clinical Trials

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Augusta University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Research Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Alexian Brothers Hospital Network

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

Southern Illinois University, School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Research Site

City

Gaithersburg

State/Province

Maryland

ZIP/Postal Code

20877

Country

United States

Facility Name

Cherry Health

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Research Site

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

St. Louis Clinical Trials, LC

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Hassman Research Institute

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

UB Department Psychiatry

City

Buffalo

State/Province

New York

ZIP/Postal Code

104051

Country

United States

Facility Name

Neurobehavioral Research, Inc.

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

Finger Lakes Clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

The Ohio State University Department of Psychiatry

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Research Site

City

North Canton

State/Province

Ohio

ZIP/Postal Code

44720

Country

United States

Facility Name

Research Site

City

Richardson

State/Province

Texas

ZIP/Postal Code

75080

Country

United States

Facility Name

The University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

Facility Name

Research Site

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

Zentrum für klinische Forschung Dr. med. I. Schöll

City

Bad Homburg

State/Province

Hessen

ZIP/Postal Code

61348

Country

Germany

Facility Name

Clinic for Psychiatrie

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60528

Country

Germany

Facility Name

Universitätsmedizin Göttingen, Klinik für Psychiatrie und Psychotherapie

City

Westerstede

State/Province

Niedersachsen

ZIP/Postal Code

26655

Country

Germany

Facility Name

Dpt of Psychiatry and Psychotherapy, University of Leipzig

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Research Site

City

Anan-shi

Country

Japan

Facility Name

Research Site

City

Ichikawa-shi

Country

Japan

Facility Name

Research Site

City

Kashihara-shi

Country

Japan

Facility Name

Research Site

City

Kawasaki-shi

Country

Japan

Facility Name

Research Site

City

Kita-gun

Country

Japan

Facility Name

Research Site

City

Kodaira-shi

Country

Japan

Facility Name

Research Site

City

Kumagaya-shi

Country

Japan

Facility Name

Research Site

City

Takasaki-shi

Country

Japan

Facility Name

Research Site

City

Yokosuka-shi

Country

Japan

Facility Name

Research Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Hospital Universitario Marques Valdecilla

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Research Site

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Unidad Neurociencias CS San Juan

City

Salamanca

ZIP/Postal Code

37005

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Oxford Health NHS Foundation Trust

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 7JX

Country

United Kingdom

Facility Name

Abraham Cowley Unit

City

Lyne

State/Province

Surrey

ZIP/Postal Code

KT16 0AE

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SE5 8AZ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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