Clinical trial NCT02855411: A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Official title: A 12 Week, Phase 2, Randomized, Double-blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety And Efficacy Of Pf-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cognitive Impairment Associated With Schizophrenia (CIAS)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether PF-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects

Detailed description: This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Key Inclusion Criteria:

* Otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the M.I.N.I 7.0 for Psychotic Disorders
* Evidence of stable schizophrenia symptomatology \>=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
* Subjects 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. Subjects should be on no more than 2 background antipsychotics.
* Subject must have an identified informant
* Subject must reside in a stable living situation for at least 12 weeks prior to Screening.

Key Exclusion Criteria:

* Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of the investigator.
* Subjects with a current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
* Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
* Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I 7.0 for Psychotic Disorders interview and as determined by the investigator.
* Subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Change From Baseline in the UPSA-VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment - Validation of Intermediate Measures) to Week 12
timeFrame: Baseline, Week 6, Week 12
Secondary outcomes:
measure: Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose
measure: Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Change From Baseline in the SCI-PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Change From Baseline in the SCI-PANSS Positive, Negative and General Psychopathology Subscales to Week 12
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Change From Baseline in the CGI-S (Clinical Global Impression-Severity) to Week 12
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: CGI-I (Clinical Global Impression-Improvement) at Week 12
timeFrame: Week 12
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: For AEs, the time frame was from taking first dose through and including last visit (28 days after the last dose), up to 113 days. For SAEs, the time frame was from the time that the participant provided informed consent to last visit, up to 143 days.
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Screening up to Week 12 or early termination
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Screening up to Week 12 or early termination
measure: Number of Participants With Potentially Clinically Significant Vital Signs Findings
timeFrame: Screening up to Week 12 or early termination
measure: Number of Participants With Abnormalities in Neurological Examination
timeFrame: Screening up to Week 12 or early termination
measure: Number of Participants With Abnormalities in Physical Examination
timeFrame: Screening up to Week 12 or early termination
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC (Investigator Site File Location)
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Atlanta
country: United States
facility: Atlanta Center For Medical Research
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Centers for Psychiatric Research
state: Illinois
city: Hoffman Estates
country: United States
facility: Chinmay K. Patel, D.O.
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health, LLC
state: Maryland
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Marlton
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: