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Trial record 1 of 1 for:    2016-001575-71
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Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

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ClinicalTrials.gov Identifier: NCT02847650
Recruitment Status : Terminated (Study B7601011 was terminated on 29 Jan 2018 due to lack of efficacy in moderate/advanced Parkinson's disease.)
First Posted : July 28, 2016
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 25, 2016
First Posted Date  ICMJE July 28, 2016
Results First Submitted Date  ICMJE December 18, 2018
Results First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE October 17, 2016
Actual Primary Completion Date January 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15 [ Time Frame: Baseline (Day -1/randomization), Week 15 ]
MDS-UPDRS Part III was used to assess the motor signs of Parkinson's disease. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The MDS-UPDRS Part III total score range is 0-132. Higher score indicates more severe motor signs of Parkinson's disease. A negative change from baseline represents an improvement in motor function.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Change from baseline in the Modified Unified Parkinson's Disease Rating Scale (MDS UPDRS) Score Part III [ Time Frame: Baseline, 15 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study treatment up to 28 days after last dose (up to Day 133) ]
    An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment.
  • Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) [ Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit ]
    Following safety laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes); chemistry (blood urea nitrogen/urea and creatinine, glucose , calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urine bilirubin, urobilinogen, urine creatinine, microscopy, and specific gravity).
  • Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria [ Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit ]
    Vital signs categorical summarization criteria: 1) supine and standing systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine and standing diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) standing pulse rate <40 or >140 bpm; 5) maximum change from baseline (increase or decrease) in supine and standing DBP greater than or equal to (>=) 20 mmHg; 6) maximum change from baseline (increase or decrease) in supine and standing SBP >=30 mmHg. Orthostatic hypotension criterion was defined as a decrease of >=20 mmHg for SBP or >=10 mmHg for DBP 2 minutes after standing from a supine position.
  • Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters [ Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit ]
    ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=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 > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.
  • Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit ]
    The C-SSRS is an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Participants with new onset suicidality were those without suicidal ideation and behavior at baseline and reported any suicidal behavior or ideation post-baseline as assessed by C-CASA code mapped from C-SSRS data. Participants with worsening suicidality were those who moved to a lower numbered C-CASA category than was reported at baseline.
  • Change From Baseline in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Total Score at Days 35, 63, and 105 [ Time Frame: Baseline (Day -1 or randomization); Days 35, 63, 105 ]
    The QUIP-RS has 4 primary questions pertaining to commonly reported thoughts, urges/desires, and behaviors associated with impulsive-compulsive disorder , each applied to the 4 impulsive-compulsive disorders (compulsive gambling, buying, eating, and sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). Each question is anchored with the following 5 responses: Never (0), Rarely (1), Sometimes (2), Often (3), and Very Often (4). The scoring range for each item (ie, disorder) is 0-16. The QUIP-RS total score range is 0-64. Higher score indicates a greater level of the impulsive compulsive disorder.
  • Total Physician Withdrawal Checklist (PWC-20) Score [ Time Frame: Day 119 ]
    The PWC-20 is a 20-item reliable and sensitive instrument for the assessment of benzodiazepine-like discontinuation symptoms. The total PWC-20 score is the sum of 20 item scores and ranges between 0 and 60. The higher score indicates more frequent/severe symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Columbia Suicide Severity Rating Scale (C SSRS) [ Time Frame: Baseline, day 7, 14, 21, 35, 49, 63, 84, 105, 119 ]
  • • Questionnaire for Impulsive Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP RS) [ Time Frame: baseline, day 35, 63, 105 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
Official Title  ICMJE A 15-week, Phase 2, Double Blind, Randomized, Placebo-controlled, Flexible Dose Study To Investigate The Efficacy, Safety And Tolerability Of Pf-06649751 In Subjects With Early Stage Parkinson's Disease
Brief Summary The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.
Detailed Description The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 88 subjects will be randomized to 2 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Placebo
    Other Name: oral tablet once daily
  • Drug: PF-06649751
    Other Name: flexible dose oral tablet once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06649751
    Intervention: Drug: PF-06649751
Publications * Riesenberg R, Werth J, Zhang Y, Duvvuri S, Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial. Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 10.1177/1756286420911296. eCollection 2020.

*   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 27, 2017)
57
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
88
Actual Study Completion Date  ICMJE January 29, 2018
Actual Primary Completion Date January 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females of non-childbearing potential and/or male subjects
  • Clinical diagnosis of Parkinson's disease.
  • Parkinson's Disease Hoehn & Yahr Stage I-III inclusive
  • Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
  • Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

  • History or presence of atypical Parkinsonian syndrome.
  • Severe acute or chronic medical or psychiatric condition or cognitive impairment or laboratory abnormality.
  • Any condition possibly affecting drug absorption.
  • Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02847650
Other Study ID Numbers  ICMJE B7601011
2016-001575-71 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP