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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2016-001575-71
    Trial protocol
    DE   ES  
    Global end of trial date
    29 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jan 2019
    First version publication date
    02 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7601011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02847650
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effect of PF-06649751 administered once daily on motor symptoms in subjects with early stage Parkinson’s disease.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 33
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Israel: 1
    Worldwide total number of subjects
    57
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    28
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted at 23 centers in the United States (US), Germany, France and Israel, from 17 October 2016 to 29 January 2018.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PF-06649751
    Arm description
    Eligible subjects were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; subjects might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-06649751
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects (and caregivers, as applicable) were instructed to take 3 tablets of the investigational product at approximately the same time each morning, swallow each tablet whole with water, and not to manipulate or chew the tablet prior to swallowing. All tablets were required to be taken within approximately 5 minutes. The tablets could be taken with or without food. The timing of the investigational product administration on each day of the double-blind treatment was documented by the subject via the subject dosing diary.

    Arm title
    Placebo
    Arm description
    Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of placebo.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects (and caregivers, as applicable) were instructed to take 3 tablets of the investigational product at approximately the same time each morning, swallow each tablet whole with water, and not to manipulate or chew the tablet prior to swallowing. All tablets were required to be taken within approximately 5 minutes. The tablets could be taken with or without food. The timing of the investigational product administration on each day of the double-blind treatment was documented by the subject via the subject dosing diary.

    Number of subjects in period 1
    PF-06649751 Placebo
    Started
    29
    28
    Completed
    25
    22
    Not completed
    4
    6
         Protocol deviation
    -
    1
         Adverse event, non-fatal
    2
    4
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-06649751
    Reporting group description
    Eligible subjects were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; subjects might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.

    Reporting group title
    Placebo
    Reporting group description
    Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of placebo.

    Reporting group values
    PF-06649751 Placebo Total
    Number of subjects
    29 28 57
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    12 16 28
        From 65-84 years
    17 12 29
        85 years and over
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    64.76 ± 8.34 63.36 ± 9.16 -
    Sex: Female, Male
    Units: Subjects
        Female
    9 14 23
        Male
    20 14 34
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    1 3 4
        White
    28 25 53
        More than one race
    0 0 0
        Unknown or Not Reported
    0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    2 1 3
        Not Hispanic or Latino
    27 27 54
        Unknown or Not Reported
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    PF-06649751
    Reporting group description
    Eligible subjects were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; subjects might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.

    Reporting group title
    Placebo
    Reporting group description
    Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of placebo.

    Primary: Change From Baseline in the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15

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    End point title
    Change From Baseline in the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15
    End point description
    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. Analysis population included all treated subjects (ie, who received at least 1 dose of study treatment [PF-06649751 or placebo]) who had a baseline and Week 15 MDS-UPDRS score Part III.
    End point type
    Primary
    End point timeframe
    Baseline (Day -1/randomization), Week 15
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    25
    22
    Units: units on a scale
        least squares mean (standard error)
    -9.0 ± 1.54
    -4.3 ± 1.65
    Statistical analysis title
    MDS-UPDRS Part III Total Score at Week 15
    Comparison groups
    Placebo v PF-06649751
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0407
    Method
    Mixed models analysis
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -4.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.6
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.26

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a subject 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. Analysis population included all treated subjects.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment up to 28 days after last dose (up to Day 133)
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    29
    28
    Units: subjects
        AEs|
    25
    18
        SAEs|
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

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    End point title
    Number of Subjects With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
    End point description
    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, alanine aminotransferase, 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). Analysis population included all treated subjects with at least 1 observation of the given laboratory test.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1/randomization) up to Day 119 follow-up visit
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    28
    28
    Units: subjects
    19
    19
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria

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    End point title
    Number of Subjects With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria
    End point description
    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. Analysis population included all subjects who received at least 1 dose of study treatment (PF-06649751 or placebo).
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1/randomization) up to Day 119 follow-up visit
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    29
    28
    Units: subjects
        Supine SBP <90 mmHg|
    0
    0
        Standing SBP <90 mmHg|
    0
    0
        Supine DBP <50 mmHg|
    0
    0
        Standing DBP <50 mmHg|
    0
    0
        Supine pulse rate <40 bpm|
    0
    0
        Supine pulse rate >120 bpm|
    0
    0
        Standing pulse rate <40 bpm|
    0
    0
        Standing pulse rate >140 bpm|
    0
    0
        Maximum increase in standing DBP >=20 mmHg|
    0
    0
        Maximum increase in standing SBP >=30 mmHg|
    0
    0
        Maximum increase in supine DBP >=20 mmHg|
    0
    1
        Maximum increase in supine SBP >=30 mmHg|
    0
    3
        Maximum decrease in standing DBP >=20 mmHg|
    8
    2
        Maximum decrease in standing SBP >=30 mmHg|
    4
    1
        Maximum decrease in supine DBP >=20 mmHg|
    9
    1
        Maximum decrease in supine SBP >=30 mmHg|
    5
    0
        SBP postural difference(supine-standing) >=20mmHg|
    1
    2
        DBP postural difference(supine-standing) >=10mmHg|
    3
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters

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    End point title
    Number of Subjects Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters
    End point description
    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. Analysis population included all treated subjects. "n" represents the number of subjects evaluable for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1/randomization) up to Day 119 follow-up visit
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    29
    28
    Units: subjects
        PR interval >=300 msec|(n=28,28)
    0
    0
        QRS duration >=140 msec|(n=29,28)
    0
    0
        QT interval >=500 msec|(n=29,28)
    0
    0
        QTcF interval >=450 to <480 msec|(n=29,28)
    0
    0
        QTcF interval >=480 to <500 msec|(n=29,28)
    0
    0
        QTcF interval >=500 msec|(n=29,28)
    0
    0
        Percent increase in PR interval >=25/50%|(n=28,28)
    0
    0
        Percent increase in QRS duration >=50%|(n=29,28)
    0
    0
        QTcF interval increase >=30 to <60 msec|(n=29,28)
    1
    2
        QTcF interval increase >=60 msec|(n=29,28)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

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    End point title
    Number of Subjects With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
    End point description
    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). Subjects 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. Subjects with worsening suicidality were those who moved to a lower numbered C-CASA category than was reported at baseline. Analysis population included all treated subjects.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1/randomization) up to Day 119 follow-up visit
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    29
    28
    Units: subjects
        Worsening suicidality|
    0
    0
        New onset suicidality|
    1
    0
    No statistical analyses for this end point

    Secondary: 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

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    End point title
    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
    End point description
    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. Analysis population included all treated subjects. "n" represents the number of subjects evaluable for this endpoint at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1 or randomization); Days 35, 63, 105
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    29
    28
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change from baseline at Day 35| (n=28,28)
    0.2 ± 5.23
    1.9 ± 9.49
        Change from baseline at Day 63| (n=27,24)
    -1.1 ± 5.99
    1.1 ± 9.02
        Change from baseline at Day 105| (n=26,22)
    -1.6 ± 4.54
    -0.2 ± 5.38
    No statistical analyses for this end point

    Secondary: Total Physician Withdrawal Checklist (PWC‑20) Score

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    End point title
    Total Physician Withdrawal Checklist (PWC‑20) Score
    End point description
    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. Analysis population included all treated subjects who had PWC-20 evaluation.
    End point type
    Secondary
    End point timeframe
    Day 119
    End point values
    PF-06649751 Placebo
    Number of subjects analysed
    28
    26
    Units: units on a scale
        median (full range (min-max))
    1.50 (0 to 12.00)
    1.00 (0 to 11.00)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study treatment up to 28 days after last dose (up to Day 133)
    Adverse event reporting additional description
    The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as non-serious in another subject, or 1 subject may have experienced both a serious and non-serious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    PF-06649751
    Reporting group description
    Eligible subjects were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; subjects might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.

    Reporting group title
    Placebo
    Reporting group description
    Matching placebo tablet for QD dosing in the 15-week double-blind treatment period. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.

    Serious adverse events
    PF-06649751 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 28 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PF-06649751 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 29 (75.86%)
    12 / 28 (42.86%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Hypotension
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Dysgeusia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Dystonia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    7 / 29 (24.14%)
    2 / 28 (7.14%)
         occurrences all number
    10
    2
    Paraesthesia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Somnolence
         subjects affected / exposed
    4 / 29 (13.79%)
    1 / 28 (3.57%)
         occurrences all number
    4
    1
    Tremor
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 28 (7.14%)
         occurrences all number
    5
    5
    Hypoaesthesia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 28 (10.71%)
         occurrences all number
    4
    3
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Anxiety
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Depression
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Insomnia
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 28 (7.14%)
         occurrences all number
    2
    2
    Irritability
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    Restlessness
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    5 / 29 (17.24%)
    0 / 28 (0.00%)
         occurrences all number
    6
    0
    Nausea
         subjects affected / exposed
    9 / 29 (31.03%)
    2 / 28 (7.14%)
         occurrences all number
    15
    2
    Diarrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 28 (10.71%)
         occurrences all number
    1
    3
    Dyspepsia
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 28 (7.14%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0
    Back pain
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 28 (3.57%)
         occurrences all number
    4
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 28 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 28 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jul 2016
    • Clarified that 104 healthy volunteer subjects have participated in the completed Phase 1 studies, with 88 having received PF-06649751. • Updated Schedule of Activities. • Included results of Study 8001294. • Updated Exclusion Criteria. • Clarified that the increase in dose level from Stage 1 to Stage 2 was a mandatory step at Visit 2 (from Day 8). • Updated additional safety laboratory tests added at Screening and Visit 15 (and during the study if deemed necessary by the investigator) for monitoring of vascular inflammation. • Added Prep B2 Banked Biospecimen sample collection at Visit 1 (Randomization) and Visit 15. • Updated blood volume table. • Included End of Trial template language. • Updated Appendix 2. • Minor administrative updates throughout. • Updated references.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was terminated early by the sponsor due to a companion study, B7601003 (a dose ranging, Phase 2b study in motor fluctuators) meeting futility criteria at Interim Analysis.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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