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

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ClinicalTrials.gov Identifier: NCT03745820
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

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.


Condition or disease Intervention/treatment Phase
Cognitive Impairment Associated With Schizophrenia Drug: BIIB104 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : January 21, 2022
Estimated Study Completion Date : February 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: BIIB104 0.5 mg
Participants will receive 0.5 mg of BIIB104 twice a day, orally, for 12 weeks.
Drug: BIIB104
Administered as specified in the treatment arm
Other Name: PF-04958242

Experimental: BIIB104 0.15 mg
Participants will receive 0.15 mg of BIIB104 twice a day, orally, for 12 weeks.
Drug: BIIB104
Administered as specified in the treatment arm
Other Name: PF-04958242

Placebo Comparator: Matching Placebo
Participants will receive matching placebo twice a day, orally, for 12 weeks.
Other: Placebo
Administered as specified in the treatment arm




Primary Outcome Measures :
  1. Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) Working Memory Domain Score to Week 12 [ Time Frame: Baseline, 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). Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 14 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject 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.

  2. Change from Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment to Week 12 [ Time Frame: Baseline, 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.

  3. Change from Baseline in Schizophrenia Cognition Rating Scale (SCoRS) assessment to Week 12 [ Time Frame: Baseline, 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. Score ranges from 1 to 10 with a higher score indicating a greater degree of impairment.

  4. Change from Baseline in MCCB Composite and Individual Domain Scores (Excluding Working Memory Domain) to Week 12 [ Time Frame: Baseline, 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). Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms.

  5. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores to Week 12 [ Time Frame: Baseline, Week 12 ]
    The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (e.g., delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (e.g., blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (e.g., somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.

  6. Change from Baseline in Clinical Global Impression-Severity (CGI-S) to Week 12 [ Time Frame: Baseline, Week 12 ]
    The CGI-S consists of a single 7-point rating score of illness severity. Raters select one response based on the following question: "Considering your total clinical experience with this particular population, how mentally ill is your participant at this time?" Scores are as follows: 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 subjects.

  7. Clinical Global Impression-Improvement (CGI-I) at Week 12 [ Time Frame: 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. Raters select one response based on the following question: "Compared to your participant's condition at the beginning of treatment, how much has your participant changed?" Scores are as follows: 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; or 7, Very much worse. For the CGI-I scale, the participant's condition at the Baseline/Day 1 Visit will be the criterion for judging improvement at subsequent visits.

  8. Scale for the Assessment and Rating of Ataxia (SARA) Score [ Time Frame: Up to Week 14 ]
    The SARA is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level and will complement 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 the worst.

  9. Columbia-Suicide Severity Rating Scale (C-SSRS) score [ Time Frame: Up to Week 14 ]
    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 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745820


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
Additional Information:
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03745820    
Other Study ID Numbers: 263CS201
2018-003825-27 ( EudraCT Number )
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders