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



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:3/17/2019
Start Date:November 15, 2018
End Date:April 20, 2020
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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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)

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.


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 ≥3 months (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 ≥2 months prior to Baseline/Day 1,
including concomitant psychotropic treatments. Doses of background atypical
antipsychotics should be within the dose range listed in approved product labeling in
the United States (US).

- PANSS: No more than moderate-severe rating (score ≤5) on hallucinations, delusions,
and hostility; PANSS positive symptom items (P1, P3, P5, P6, P7); or unusual thought
content (G9); and no more than a moderate severity rating on positive formal thought
disorder (P2).

Key Exclusion Criteria:

- Participation in a CIAS trial within the previous 6 months.

- Participation in cognitive remediation therapy within 6 months prior to randomization.

- Screening MCCB Working Memory T-score ≥60 on either the Letter Number Span or the
Wechsler Memory Scale, Third Edition (WMS-III) Spatial Span task.

- 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.
We found this trial at
17
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