A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)

NCT02855411 | Terminated Phase 2 Results DMC

• 2 other identifiers: B1701019POC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 16

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

Conditions

Cognitive Impairment Associated With Schizophrenia (CIAS)

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12

  The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.

  Baseline, Week 2, Week 6, Week 12

• Change From Baseline in the UPSA-VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment - Validation of Intermediate Measures) to Week 12

  The UPSA-VIM is a functional capacity measure of 5 general skills that were previously identified as essential to functioning in the community: general organization, finance, social/communications, transportation, and household chores. The UCSD Performance Based Skills Assessment involves role play tasks that are administered as simulations of events that the person might encounter in the community.

  Baseline, Week 6, Week 12

Secondary Outcomes (15)

• Scale for the Assessment and Rating of Ataxia (SARA)

  Baseline, Week 2, Week 6, Week 12

• Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose

• Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12

  Baseline, Week 2, Week 6, Week 12

• Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12

  Baseline, Week 2, Week 6, Week 12

• Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12

  Baseline, Week 2, Week 6, Week 12

Study Arms (3)

0.15 mg PF-04958242

EXPERIMENTAL

Participants received 0.15 mg oral capsule, twice daily (BID) for 12 weeks

Drug: PF-04958242

0.5 mg PF-04958242

EXPERIMENTAL

Participants received 0.5 mg oral capsule, twice daily (BID) for 12 weeks

Drug: PF-04958242

Placebo

PLACEBO COMPARATOR

Participants received matching placebo oral capsule, twice daily (BID) for 12 weeks

Drug: placebo

Interventions

PF-04958242 DRUG

Administered as specified in the treatment arm

0.15 mg PF-04958242; 0.5 mg PF-04958242

placebo DRUG

placebo, twice daily (BID) for 12 weeks, capsule

Also known as: Administered as specified in the treatment arm

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (16)

Collaborative Neuroscience Network, LLC (Investigator Site File Location)

Garden Grove, California, 92845, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)

San Diego, California, 92102, United States

Location

Collaborative Neuroscience Network, LLC

Torrance, California, 90502, United States

Location

Atlanta Center For Medical Research

Atlanta, Georgia, 30331, United States

Location

Alexian Brothers Centers for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Chinmay K. Patel, D.O.

Hoffman Estates, Illinois, 60169, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

CBH Health, LLC

Gaithersburg, Maryland, 20877, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

CRI Worldwide, LLC

Marlton, New Jersey, 08053, United States

Location

Research Strategies of Memphis, LLC

Memphis, Tennessee, 38119, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Interventions

PF-04958242

Limitations and Caveats

This study was terminated due to Pfizer portfolio prioritization. No participants had been randomized to receive study drug or placebo. There is no safety or efficacy data to report for this study.

Results Point of Contact

• Title: Biogen Study Medical Director
• 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 4, 2016
• Study Start: August 29, 2016
• Primary Completion: September 26, 2016
• Study Completion: September 26, 2016
• Last Updated: January 9, 2020
• Results First Posted: October 4, 2017

Record last verified: 2019-12

Locations

US (16)