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    Clinical Trial Results:
    A Phase 2, Open-label Extension Study to Investigate the Long term Safety and Tolerability of PF-06649751 in Subjects with Motor Fluctuations due to Parkinson’s Disease

    Summary
    EudraCT number
    		 2017-000128-81
    Trial protocol
    		 DE   ES  
    Global end of trial date
    25 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2019
    First version publication date
    13 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7601017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03185481
    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., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc, +1 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
    18 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the long term safety and tolerability of PF-06649751 administered once daily (QD) in subjects with 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 subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2017
    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: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    0
    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)
    2
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Five (5) subjects were assigned to treatment and treated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    The study was single-blinded 4 subjects who were delayed rollover subjects, and double-blinded for 1 subject who was direct rollover subject.

    Arms
    Arm title
    		 PF-06649751 15 mg
    Arm description
    		 Participants who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.
    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
    PF-06649751 were orally administered once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.

    Number of subjects in period 1
    		PF-06649751 15 mg
    Started
    5
    Completed
    0
    Not completed
    5
         Adverse event, non-fatal
    1
         Study Terminated by Sponsor
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-06649751 15 mg
    Reporting group description
    		 Participants who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.

    Reporting group values
    		 PF-06649751 15 mg Total
    Number of subjects
    		 5 5
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 63 ( 11.73 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 0 0
        Male
    		 5 5
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 5 5
        Black or African American
    		 0 0
        Asian
    		 0 0
        American Indian or Alaska Native
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Other
    		 0 0
        Unknown
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 5 5
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    PF-06649751 15 mg
    Reporting group description
    		 Participants who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo participants starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.

    Primary: Number of Subjects with Treatment-Emergent Adverse Events (All Causalities)

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    End point title
    		 Number of Subjects with Treatment-Emergent Adverse Events (All Causalities) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a study subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Subjects
    3
    No statistical analyses for this end point

    Primary: Number of Subjects with Treatment-Emergent Adverse Events (Treatment Related)

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    End point title
    		 Number of Subjects with Treatment-Emergent Adverse Events (Treatment Related) [2]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a study subject administered a product or medical device. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Subjects
    2
    No statistical analyses for this end point

    Primary: Number of Subjects with Clinically Significant Findings in Physical Examination

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    End point title
    		 Number of Subjects with Clinically Significant Findings in Physical Examination [3]
    End point description
    A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems. The brief physical examination was focused on general appearance, pulmonary, abdominal exams, the respiratory and cardiovascular systems, as well as towards subjects reported symptoms. The clinical significance was determined by the investigator.
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    3
    Units: Subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Clinically Significant Findings in Neurological Examination

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    End point title
    		 Number of Subjects with Clinically Significant Findings in Neurological Examination [4]
    End point description
    The full neurological examination included assessment of the visual fields and of the right and left optic fundus; cranial nerves; mental state; muscle strength and tone, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. The brief neurological exam included observation for cerebellar (intention) tremor and for non cerebellar tremors (eg, resting or positional), finger to nose, heel to shin, Romberg, gait and tandem walking, positional and gaze evoked nystagmus. The clinical significance was determined by the investigator.
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    4
    Units: Subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)

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    End point title
    		 Number of Subjects with Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality) [5]
    End point description
    Laboratory tests included hematology(hemoglobin,hematocrit,red and white blood cell count,mean corpuscular volume,mean corpuscular hemoglobin,mean corpuscular hemoglobin concentration,platelet count,neutrophils,eosinophils,monocytes, basophils,lymphocytes), chemistry(blood urea nitrogen/urea and creatinine,fasting glucose, calcium,sodium,potassium, chloride,total carbon dioxide,aspartate and alanine aminotransferase,total bilirubin,alkaline phosphatase,uric acid,albumin,total protein),urinalysis(pH,qualitative glucose protein,blood,ketones,nitrites,leukocyte esterase,urobilinogen,urine bilirubin,microscopy,specific gravity,urine creatinine),other tests(urine drug screen,follicle stimulating hormone,anti neutrophil cytoplasmic antibody panel,qualitative antinuclear antibody,fibrinogen,C reactive protein,erythrocyte sedimentation rate,C3, C4, CH50/CH100,rheumatoid factor,immunoglobulin panel,if anti- neutrophil cytoplasmic antibody positive:proteinase 3 Ab,myeloperoxidase Ab tests).
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination(up to approximately 3 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Subjects
    1
    No statistical analyses for this end point

    Primary: Number of Subjects with Vital Signs Data Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects with Vital Signs Data Meeting Pre-defined Criteria [6]
    End point description
    Number of subjects with vital signs findings meeting the following criteria is presented:(1) standing diastolic blood pressure (DBP) increase from baseline>= 20 mm Hg; (2) standing SBP increase from baseline>= 30 mm Hg; (3) supine DBP increase from baseline >=20 mm Hg; (4) supine systolic blood pressure (SBP) increase from baseline >=30 mm Hg; (5)standing DBP decrease from baseline>= 20 mm Hg; (6) standing SBP decrease from baseline>= 30 mm Hg; (7) supine DBP decrease from baseline >=20 mm Hg; (8) supine SBP decrease from baseline >=30 mm Hg.
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Subjects
        Standing DBP increase from baseline >= 20 mm Hg
    0
        Standing SBP increase from baseline >= 30 mm Hg
    1
        Supine DBP increase from baseline >= 20 mm Hg
    0
        Supine SBP increase from baseline >= 30 mm Hg
    2
        Standing DBP decrease from baseline >= 20 mm Hg
    0
        Standing SBP decrease from baseline >= 30 mm Hg
    0
        Supine DBP decrease from baseline >= 20 mm Hg
    0
        Supine SBP decrease from baseline >= 30 mm Hg
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects with Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria [7]
    End point description
    Orthostatic hypotension was defined as a decrease of >=20 mmHg for systolic blood pressure (SBP) or >=10 mmHg for diastolic blood pressure (DBP) 2 minutes after standing from a supine position.
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Subjects
        DBP postural difference>=10 mmHg(Supine-Standing)
    3
        SBP postural difference>=20 mmHg(Supine-Standing)
    4
    No statistical analyses for this end point

    Primary: Number of Subjects with Electrocardiogram Data Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects with Electrocardiogram Data Meeting Pre-defined Criteria [8]
    End point description
    PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), QT interval (time from the beginning of Q wave to the end of T wave) and QTcF interval ( QT interval corresponding to electrical systole corrected for heart rate using Fridericia’s formula) are summarized. Number of subjects with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS duration >=140 msec; (3) QT interval >= 500; (4) QTcF interval: 450 to <480 msec; (5) QTcF interval: 480 to <500 msec; (6) QTcF interval >=500 msec.
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Subjects
        PR Interval (aggregate) >= 300 msec
    0
        QRS Duration (aggregate) >= 140 msec
    0
        QT Interval (aggregate) >= 500 msec
    0
        QTcF Interval (aggregate) >= 450 msec, <480msec
    0
        QTcF Interval (aggregate) >= 480 msec, <500msec
    0
        QTcF Interval (aggregate) >= 500 msec
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Worsening Suicidality and New Onset Suicidality

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    End point title
    		 Number of Subjects with Worsening Suicidality and New Onset Suicidality [9]
    End point description
    The Columbia Suicide Severity Rating Scale (C-SSRS) is an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. At each suicidality assessment, subjects felt to have significant suicidal ideation with actual plan and intent or suicidal behavior, must be evaluated by a clinician/mental health professional (MHP) skilled in the evaluation of suicidality in the subjects by virtue of training or experience who determined if it is safe for the subjects to participate/continue in the trial. The denominator used in the percentages was the number of subjects assessed for suicidality or worsening, the denominator included the subset of subjects who had any level of suicidality reported at baseline. For new onset, the denominator included the subset of subjects with no suicidality reported at baseline.
    End point type
    Primary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Subjects
        New Onset
    0
        Worsening
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)

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    End point title
    		 Number of Subjects With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20) [10]
    End point description
    The PWC-20 is a physician-completed, 20-item reliable and sensitive instrument for the assessment of benzodiazepine discontinuation symptoms, including anxiety and nervous, depersonalization and derealization, diarrhea, diaphoresis, difficulty concentrating and remembering, dizziness-lightheadedness, depression, fatigue, lethargy and lack of energy, headaches, increased acuity for sound, smell, touch, or pain, insomnia, irritability, loss of appetite, muscle aches or stiffness, nausea-vomiting paresthesias, poor coordination, restlessness and agitation, tremor-tremulousness, and weakness. Summaries of the count of subjects experiencing symptoms and severity listed in the PWC-20 were provided.
    End point type
    Primary
    End point timeframe
    At last visit
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    4
    Units: Subjects
        Anxiety, Nervousness: Not Present
    3
        Difficult Concentrating, Remembering: Not Present
    3
        Dysphoric Mood, Depression: Not Present
    3
        Fatigue, Lethargy, Lack of Energy: Not Present
    2
        Insomnia: Not Present
    2
        Irritability: Not Present
    3
        Muscle Aches or Stiffness: Not Present
    3
        Poor Coordination: Not Present
    2
        Restlessness, Agitation: Not Present
    3
        Tremor-Tremulousness: Not Present
    3
        Weakness: Not Present
    2
        Anxiety, Nervousness: Mild
    1
        Difficult Concentrating, Remembering: Mild
    1
        Dysphoric Mood, Depression: Mild
    1
        Fatigue, Lethargy, Lack of Energy: Mild
    1
        Insomnia: Mild
    1
        Irritability: Mild
    0
        Muscle Aches or Stiffness: Mild
    0
        Poor Coordination: Mild
    1
        Restlessness, Agitation: Mild
    0
        Tremor-Tremulousness: Mild
    0
        Weakness: Mild
    2
        Anxiety, Nervousness: Moderate
    0
        Difficult Concentrating, Remembering: Moderate
    0
        Dysphoric Mood, Depression: Moderate
    0
        Fatigue, Lethargy, Lack of Energy: Moderate
    1
        Insomnia: Moderate
    1
        Irritability: Moderate
    1
        Muscle Aches or Stiffness: Moderate
    1
        Poor Coordination: Moderate
    1
        Restlessness, Agitation: Moderate
    1
        Tremor-Tremulousness: Moderate
    0
        Weakness: Moderate
    0
        Anxiety, Nervousness: Severe
    0
        Difficult Concentrating, Remembering: Severe
    0
        Dysphoric Mood, Depression: Severe
    0
        Fatigue, Lethargy, Lack of Energy: Severe
    0
        Insomnia: Severe
    0
        Irritability: Severe
    0
        Muscle Aches or Stiffness: Severe
    0
        Poor Coordination: Severe
    0
        Restlessness, Agitation: Severe
    0
        Tremor-Tremulousness: Severe
    1
        Weakness: Severe
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline for Hauser Subject Diary Data in Daily OFF Time

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    End point title
    		 Change from Baseline for Hauser Subject Diary Data in Daily OFF Time
    End point description
    Available diaries are designed to record subjects motor state for half hour intervals. These diaries are a way for subjects to assess their own health status without clinician bias or interpretation. In subjects diaries, “OFF” time is defined as a period when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. During this period, Parkinson's Disease (PD) subjects experience relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 21 and Day 35
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    1
    Units: Hours
    arithmetic mean (standard deviation)
        Baseline
    3.25 ( 0 )
        Day 21
    0.00 ( 0 )
        Day 35
    -0.42 ( 0 )
    No statistical analyses for this end point

    Secondary: Change from Baseline for Hauser Subject Diary Data in Daily ON Time with Troublesome Dyskinesia

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    End point title
    		 Change from Baseline for Hauser Subject Diary Data in Daily ON Time with Troublesome Dyskinesia
    End point description
    Available diaries are designed to record subjects motor state for half hour intervals. These diaries are a way for subjects to assess their own health status without clinician bias or interpretation. “ON” time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. “ON” time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living.It has been demonstrated that “ON” time with troublesome dyskinesia are generally considered by subjects to be “bad time” with regard to motor function.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 21 and Day 35
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    1
    Units: Hours
    arithmetic mean (standard deviation)
        Baseline
    0.00 ( 0 )
        Day 21
    0.00 ( 0 )
        Day 35
    0.00 ( 0 )
    No statistical analyses for this end point

    Secondary: Change from Baseline for Hauser Subject Diary Data in Daily ON Time Without Troublesome Dyskinesia

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    End point title
    		 Change from Baseline for Hauser Subject Diary Data in Daily ON Time Without Troublesome Dyskinesia
    End point description
    Available diaries are designed to record subjects motor state for half hour intervals. These diaries are a way for subjects to assess their own health status without clinician bias or interpretation. “ON” time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. “ON” time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living. “ON” time without dyskinesia and on time with non troublesome dyskinesia are generally considered to be “good time”.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 21 and Day 35
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    1
    Units: Hours
    arithmetic mean (standard deviation)
        Baseline
    9.58 ( 0 )
        Day 21
    1.17 ( 0 )
        Day 35
    2.42 ( 0 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, III, IV, and Total Score

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    End point title
    		 Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, III, IV, and Total Score
    End point description
    The total MDS-UPDRS score developed by the Movement Disorder Society is the most common method of evaluating the severity of Parkinson's Disease (PD) across behaviors, activities of daily living, motor abilities, and other complications of PD. Part I assesses non motor experiences of daily living and is comprised of two components assessed by investigator and subjects respectively.Part II assesses motor experiences of daily living. There are an additional 13 questions that are also part of the Subject Questionnaire completed by the subjects. Part III assesses the motor signs of PD and is administered by the investigator.Part IV assesses motor complications, dyskinesias, and motor fluctuations using historical and objective information.
    End point type
    Secondary
    End point timeframe
    Baseline to last visit after termination (up to approximately 3 months)
    End point values
    		 PF-06649751 15 mg
    Number of subjects analysed
    5
    Units: Units on a scale
    median (full range (min-max))
        Part I Score
    -1.5 (-15 to 9)
        Part II Score
    0 (-10 to 9)
        Part III Score
    -2.5 (-9 to 11)
        Part IV Score
    0 (-3 to 6)
        Total Score
    0 (-32 to 19)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to last visit after termination (up to approximately 3 months)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    PF-06649751 15 mg
    Reporting group description
    		 Subjects who completed Week 15 in Study B7601003 (NCT02687542) were orally administered PF-06649751 once daily (QD) at the last dose level used in Study B7601003 (1 mg, 3 mg, 7 mg or 15 mg, and original placebo subjects starting from 1 mg) titrated up to 15 mg during a 3-week titration period, followed by a 2-week dose adjustment period (15 mg or if intolerance, reduced to 7 mg) and then followed by open-label maintenance treatment of PF-06649751 15 mg QD for 44 weeks or until discontinuation.

    Serious adverse events
    		 PF-06649751 15 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Hip Fracture
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 PF-06649751 15 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Vascular disorders
    Orthostatic hypotention
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2017
    Updated Schedule of Activities and Section1, 2, 3, 4, 5, 6, 7 , 9 and 13; Added new Appendix 4; updated Appendix 3 reference

    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 early terminated,not due to safety concern, but lack of sufficient demonstrated efficacy of the study drug to help improve PD symptoms in the parent study B7601003.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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