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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855411
Recruitment Status : Terminated (Terminated prematurely Sept 22, 2016 following an internal portfolio prioritization. It is not due to any safety concern or change in benefit:risk assessment.)
First Posted : August 4, 2016
Results First Posted : October 4, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

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

Condition or disease Intervention/treatment Phase
Cognitive Impairment Associated With Schizophrenia (CIAS) Drug: PF-04958242 Drug: placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 29, 2016
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 0.15 mg PF-04958242
Participants received 0.15 mg oral capsule, twice daily (BID) for 12 weeks
Drug: PF-04958242
Administered as specified in the treatment arm

Experimental: 0.5 mg PF-04958242
Participants received 0.5 mg oral capsule, twice daily (BID) for 12 weeks
Drug: PF-04958242
Administered as specified in the treatment arm

Placebo Comparator: Placebo
Participants received matching placebo oral capsule, twice daily (BID) for 12 weeks
Drug: placebo
placebo, twice daily (BID) for 12 weeks, capsule
Other Name: Administered as specified in the treatment arm




Primary Outcome Measures :
  1. Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12 [ Time Frame: Baseline, Week 2, Week 6, 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.

  2. Change From Baseline in the UPSA-VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment - Validation of Intermediate Measures) to Week 12 [ Time Frame: Baseline, Week 6, 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.


Secondary Outcome Measures :
  1. Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: Baseline, Week 2, Week 6, Week 12 ]
    SARA is a clinical scale that is based on a semi--quantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.

  2. Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose ]
    C-SSRS responses are mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). C-SSRS assesses whether participant experienced following: completed suicide (Category 1); suicide attempt (Category 2) (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior (Category 3) ("Yes" on "aborted attempt", or "interrupted attempt", or "preparatory acts or behavior"); suicidal ideation (Category 4) ("Yes" on "wish to be dead", or "non-specific active suicidal thoughts", or "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"); self-injurious behavior, no suicidal intent (Category 7) ("Yes" on "has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories was to be assessed.

  3. Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12 [ Time Frame: Baseline, Week 2, Week 6, 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. The MCCB neurocognitive score contains all of the tests and domains of the MCCB composite score with the exception of social cognition.

  4. Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12 [ Time Frame: Baseline, Week 2, Week 6, 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.

  5. Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12 [ Time Frame: Baseline, Week 2, Week 6, 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.

  6. Change From Baseline in the SCI-PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12 [ Time Frame: Baseline, Week 2, Week 6, Week 12 ]
    The SCI-PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The sum of the 30 items is defined as the total score.

  7. Change From Baseline in the SCI-PANSS Positive, Negative and General Psychopathology Subscales to Week 12 [ Time Frame: Baseline, Week 2, Week 6, Week 12 ]
    The SCI--PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The Subscale scores are the sum of corresponding individual items.

  8. Change From Baseline in the CGI-S (Clinical Global Impression-Severity) to Week 12 [ Time Frame: Baseline, Week 2, Week 6, Week 12 ]
    The CGI--S consists of a single 7 point rating score of illness severity. Raters select 1 response based on the following question, "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" Scores are: 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 participants.

  9. CGI-I (Clinical Global Impression-Improvement) 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 1 response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 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, the participant's condition at the Day 1 (baseline) visit is the criterion for judging improvement at subsequent visits.

  10. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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. ]
    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) occurring following start of treatment or increasing in severity in any period were to be considered as a treatment emergent AE.

  11. Number of Participants With Laboratory Test Abnormalities [ Time Frame: Screening up to Week 12 or early termination ]
    Number of participants with laboratory test abnormalities without regard to baseline abnormality is assessed. Laboratory test parameters include hematology, clinical chemistry, urinalysis, follicle stimulating hormone, urine drug screen, and pregnancy test.

  12. Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: Screening up to Week 12 or early termination ]
    ECG criteria of potential clinical concern: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): greater than or equal to (>=) 140 milliseconds (msec), >=50% increase from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% increase when baseline is greater than (>) 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected using Fridericia's formula): absolute value of 450 to less than (<) 480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.

  13. Number of Participants With Potentially Clinically Significant Vital Signs Findings [ Time Frame: Screening up to Week 12 or early termination ]
    Vital signs criteria of potential clinical concern: 1) systolic blood pressure <90 millimeters of mercury (mm Hg); 2) change from baseline of systolic blood pressure >=30 mm Hg; 3) diastolic blood pressure <50 mm Hg; 4) change from baseline of diastolic blood pressure >=20 mm Hg; 5) supine pulse rate <40 or >120 beats per minute (bpm); 6) standing pulse rate <40 or >140 bpm.

  14. Number of Participants With Abnormalities in Neurological Examination [ Time Frame: Screening up to Week 12 or early termination ]
    The extended neurological examination includes observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze-evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination includes an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function is complemented by the Scale for the Assessment and Rating of Ataxia (SARA), a clinical scale based on a semi-quantitative assessment of cerebellar ataxia on an impairment level.

  15. Number of Participants With Abnormalities in Physical Examination [ Time Frame: Screening up to Week 12 or early termination ]
    A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination is focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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): NCT02855411


Locations
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United States, California
Collaborative Neuroscience Network, LLC (Investigator Site File Location)
Garden Grove, California, United States, 92845
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
Excell Research, Inc
Oceanside, California, United States, 92056
NRC Research Institute
Orange, California, United States, 92868
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
San Diego, California, United States, 92102
Collaborative Neuroscience Network, LLC
Torrance, California, United States, 90502
United States, Georgia
Atlanta Center For Medical Research
Atlanta, Georgia, United States, 30331
United States, Illinois
Alexian Brothers Centers for Psychiatric Research
Hoffman Estates, Illinois, United States, 60169
Chinmay K. Patel, D.O.
Hoffman Estates, Illinois, United States, 60169
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
United States, Maryland
CBH Health, LLC
Gaithersburg, Maryland, United States, 20877
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
CRI Worldwide, LLC
Marlton, New Jersey, United States, 08053
United States, Tennessee
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States, 38119
United States, Texas
Pillar Clinical Research, LLC
Dallas, Texas, United States, 75243
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02855411    
Other Study ID Numbers: B1701019
POC ( Other Identifier: Alias Study Number )
First Posted: August 4, 2016    Key Record Dates
Results First Posted: October 4, 2017
Last Update Posted: January 9, 2020
Last Verified: December 2019
Additional relevant MeSH terms:
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Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders