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

Last updated on December 12, 2019

FOR MORE INFORMATION
Study Location
Collaborative Neuroscience Network, LLC (Investigator Site File Location)
Garden Grove, California, 92845 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cognitive Impairment Associated With Schizophrenia (CIAS)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02855411
Pfizer
Terminated
A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)

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Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cognitive Impairment Associated With Schizophrenia (CIAS)
Intervention  ICMJE
  • Drug: PF-04958242
    0.15 mg or 0.5 mg, twice daily (BID) for 12 weeks, capsule
  • Drug: placebo
    placebo, twice daily (BID) for 12 weeks, capsule
Study Arms  ICMJE
  • Experimental: 0.15 mg PF-04958242
    Intervention: Drug: PF-04958242
  • Experimental: 0.5 mg PF-04958242
    Intervention: Drug: PF-04958242
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 12, 2016)
35
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
252
Actual Study Completion Date  ICMJE September 26, 2016
Actual Primary Completion Date September 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02855411
Other Study ID Numbers  ICMJE B1701019
POC ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date November 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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