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Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia

Last updated on February 18, 2020

FOR MORE INFORMATION
Study Location
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Psychiatrically stable (≥3 months) male and female subjects with schizophrenia of
non-childbearing potential between the ages of 18 and 55 years, inclusive.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121
lbs).

- DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ≥2 months.

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

- Suicide attempt within 3 months prior to screening.

- History of or risk of seizures; head injury with long term abnormal resulting
condition, abnormal EEG, clinically significant additional diseases or conditions,
current medication with a significant risk of seizures, currently receiving
antipsychotic medications.

NCT02332798
Pfizer
Completed
Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia

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Descriptive Information
Brief Title  ICMJE Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia
Official Title  ICMJE A Randomized, Double-blind, Placebo Controlled, Sponsor Open, Parallel Group Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Doses Of Pf-04958242 In Subjects With Stable Schizophrenia
Brief Summary This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.
Detailed Description

This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects with stable schizophrenia.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: PF-04958242
    Administered as specified in the treatment arm
  • Drug: Placebo
    Administered as specified in the treatment arm
Study Arms  ICMJE
  • Experimental: Cohort 1
    Participants received PF-04958242 oral capsule, 0.20 mg, twice a day for 14 days
    Intervention: Drug: PF-04958242
  • Experimental: Cohort 2
    Participants received PF-04958242 oral capsule, 0.35 mg, twice a day for 14 days
    Intervention: Drug: PF-04958242
  • Placebo Comparator: Matching Placebo
    Participants received matching placebo oral capsule, twice a day dosing for 14 days
    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 Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)
39
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2015)
36
Actual Study Completion Date  ICMJE April 15, 2015
Actual Primary Completion Date April 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Psychiatrically stable (?3 months) male and female subjects with schizophrenia of non-childbearing potential between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121 lbs).
  • DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ?2 months.

Key Exclusion Criteria:

  • Suicide attempt within 3 months prior to screening.
  • History of or risk of seizures; head injury with long term abnormal resulting condition, abnormal EEG, clinically significant additional diseases or conditions, current medication with a significant risk of seizures, currently receiving antipsychotic medications.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 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 NCT02332798
Other Study ID Numbers  ICMJE B1701017
MAD ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
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 December 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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