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    Clinical Trial Results:
    A Phase 2, Randomized, Placebo Controlled, Double Blind Proof-of-Concept Study of the Efficacy and Safety of PF-02545920 in Subjects With Huntington’s Disease

    Summary
    EudraCT number
    		 2014-001291-56
    Trial protocol
    		 DE   GB  
    Global end of trial date
    04 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Sep 2017
    First version publication date
    23 Sep 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A8241021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02197130
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 The Amaryllis Study: Alias
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 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
    30 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of 26-week oral daily dosing with PF-02545920 on motor function in subjects with Huntington'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 Conference on 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
    18 Sep 2014
    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
    Canada: 17
    Country: Number of subjects enrolled
    Germany: 88
    Country: Number of subjects enrolled
    Poland: 31
    Country: Number of subjects enrolled
    United Kingdom: 69
    Country: Number of subjects enrolled
    United States: 67
    Worldwide total number of subjects
    272
    EEA total number of subjects
    188
    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)
    268
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 272 subjects (133 males and 139 females) were randomized and assigned study treatment, of which 270 subjects received their treatments from the baseline.

    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-02545920 20 mg BID
    Arm description
    		 The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-02545920
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Subjects took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Arm title
    		 PF-02545920 5 mg BID
    Arm description
    		 Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-02545920
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Arm title
    		 Placebo
    Arm description
    		 Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.
    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 took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Number of subjects in period 1
    		PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Started
    88
    95
    89
    Received treatment
    87
    95
    88
    Completed
    56
    79
    81
    Not completed
    32
    16
    8
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    4
    -
    3
         Does not meet entrance criteria
    1
    -
    -
         Adverse event, non-fatal
    23
    13
    4
         Unspecified
    3
    1
    -
         Lost to follow-up
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-02545920 20 mg BID
    Reporting group description
    		 The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Reporting group title
    PF-02545920 5 mg BID
    Reporting group description
    		 Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Reporting group values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo Total
    Number of subjects
    		 88 95 89 272
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 86 93 89 268
        From 65-84 years
    		 2 2 0 4
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.3 ± 9.2 48.3 ± 8.6 50.3 ± 9.4 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 43 42 54 139
        Male
    		 45 53 35 133

    End points

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    End points reporting groups
    Reporting group title
    PF-02545920 20 mg BID
    Reporting group description
    		 The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Reporting group title
    PF-02545920 5 mg BID
    Reporting group description
    		 Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Primary: Change from Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.

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    End point title
    		 Change from Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.
    End point description
    The UHDRS is a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment scores is the sum of all the individual motor ratings, with higher scores indicating more severe motor impairment than lower scores.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    59
    83
    80
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.4 ± 8.63
    -0.8 ± 7.3
    -1.4 ± 6.67
    Statistical analysis title
    		 Change from Baseline in TMS Assessment of UHDRS
    Statistical analysis description
    Baseline, Week 26
    Comparison groups
    PF-02545920 20 mg BID v Placebo
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2033
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.52
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 3.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.192
    Statistical analysis title
    		 Change from Baseline in TMS Assessment of UHDRS
    Statistical analysis description
    Baseline, Week 26
    Comparison groups
    PF-02545920 5 mg BID v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7549
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.118

    Secondary: Number of Subjects that Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria

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    End point title
    		 Number of Subjects that Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria
    End point description
    The criteria for temporary study suspension was as follow: Criterion A: WBC count <=3000 cells/mm3 but >= 2000 cells/mm3 or ANC <= 1500 cells/mm3 but >= 1000 cells/mm3; Criterion B: WBC <= 2000 cells/mm3 or ANC <= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC <= 500 cells/mm3
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: subjects
        Criterion A
    0
    1
    0
        Criterion B
    0
    0
    0
        Criterion C
    0
    0
    0
        Criterion D
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events

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    End point title
    		 Number of Subjects with Adverse Events
    End point description
    Adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.
    End point type
    Secondary
    End point timeframe
    Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: subjects
    76
    82
    63
    No statistical analyses for this end point

    Secondary: Number of Subjects with Serious Adverse Events

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    End point title
    		 Number of Subjects with Serious Adverse Events
    End point description
    Adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (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 or incapacity, congenital anomaly.
    End point type
    Secondary
    End point timeframe
    Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: subjects
    8
    2
    7
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects with Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)
    End point description
    Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    86
    95
    88
    Units: subjects
    47
    46
    48
    No statistical analyses for this end point

    Secondary: Number of Subjects with Laboratory Test Abnormalities (With Normal Baseline)

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    End point title
    		 Number of Subjects with Laboratory Test Abnormalities (With Normal Baseline)
    End point description
    Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    86
    95
    88
    Units: subjects
    40
    36
    41
    No statistical analyses for this end point

    Secondary: Number of Subjects with Vital Sign Data that Met Criteria for Potential Clinical Concern (Absolute Values)

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    End point title
    		 Number of Subjects with Vital Sign Data that Met Criteria for Potential Clinical Concern (Absolute Values)
    End point description
    Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (<) 90 millimeter of mercury(mmHg); Criterion B: standing SBP < 90 mmHg; Criterion C: supine DBP <50 mmHg; Criterion D: standing DBP <50 mmHg; Criterion E: supine pulse rate < 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (>)120 BPM; Criterion G: standing pulse rate < 40 beats per minute(BPM); Criterion H: standing pulse rate >120 BPM;
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 28, 91, and 182
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: subjects
        Criterion A
    1
    0
    0
        Criterion B
    3
    2
    3
        Criterion C
    2
    1
    1
        Criterion D
    1
    3
    0
        Criterion E
    0
    0
    0
        Criterion F
    0
    0
    1
        Criterion G
    0
    0
    0
        Criterion H
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Vital Sign Data that Met Criteria for Potential Clinical Concern (Increase from Baseline)

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    End point title
    		 Number of Subjects with Vital Sign Data that Met Criteria for Potential Clinical Concern (Increase from Baseline)
    End point description
    The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (>=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP >= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP >=20 mmHg; Criterion D: maximum increase from baseline in standing DBP >=20 mmHg
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 28, 91, and 182
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: subjects
        Criterion A
    4
    1
    4
        Criterion B
    7
    8
    6
        Criterion C
    3
    3
    10
        Criterion D
    3
    8
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects with Vital Sign Data that Met Criteria for Potential Clinical Concern (Decrease from Baseline)

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    End point title
    		 Number of Subjects with Vital Sign Data that Met Criteria for Potential Clinical Concern (Decrease from Baseline)
    End point description
    The number of subjects with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP >= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP >=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP >=20 mmHg
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 28, 91, and 182
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: subjects
        Criterion A
    1
    7
    3
        Criterion B
    9
    8
    9
        Criterion C
    8
    6
    8
        Criterion D
    10
    14
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects with Electrocardiogram (ECG) Data that Met Criteria for Potential Clinical Concern(Absolute Values)

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    End point title
    		 Number of Subjects with Electrocardiogram (ECG) Data that Met Criteria for Potential Clinical Concern(Absolute Values)
    End point description
    The number of subjects with ECG absolute values meeting the following criteria was reported: Criterion A: maximum 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) >=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia’s formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia’s correction) >=500 msec
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 28, 91, and 182
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    86
    93
    88
    Units: subjects
        Criterion A
    0
    0
    0
        Criterion B
    0
    0
    0
        Criterion C
    5
    2
    7
        Criterion D
    0
    0
    0
        Criterion E
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Electrocardiogram (ECG) Data that Met Criteria for Potential Clinical Concern(Increase from Baseline)

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    End point title
    		 Number of Subjects with Electrocardiogram (ECG) Data that Met Criteria for Potential Clinical Concern(Increase from Baseline)
    End point description
    Number of subjects with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval (Fridericia's correction) increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval (Fridericia's correction) increase from baseline change >=60 msec.
    End point type
    Secondary
    End point timeframe
    Screening, Day 1, 28, 91, and 182
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    86
    93
    88
    Units: subjects
        Criterion A
    0
    0
    0
        Criterion B
    0
    0
    0
        Criterion C
    4
    4
    6
        Criterion D
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia

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    End point title
    		 Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia
    End point description
    Adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). EPS were reported AEs of dystonia and akathisia.
    End point type
    Secondary
    End point timeframe
    Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: participants
        Dystonia(Mild)
    0
    0
    0
        Dystonia(Moderate)
    0
    0
    0
        Dystonia(Severe)
    1
    0
    0
        Akathisia(Mild)
    1
    2
    0
        Akathisia(Moderate)
    2
    1
    0
        Akathisia(Severe)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.

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    End point title
    		 Change from Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.
    End point description
    The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The Total Maximum Chorea (TMC) was a subset of the TMS assessment. It was composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment was rated from 0 to 4 (absent to prolonged). n is the number of evaluable subjects in each visit.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 13, Week 26
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    84
    95
    88
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 13 (n= 67, 83, 77)
    1.1 ± 3.92
    -0.2 ± 3.5
    -0.9 ± 2.56
        Week 26 (n=59, 83, 80)
    0.7 ± 3.81
    -0.4 ± 2.84
    -0.8 ± 2.79
    Statistical analysis title
    		 Change from Baseline in TMC Score of the UHDRS
    Statistical analysis description
    Baseline, Week 13
    Comparison groups
    PF-02545920 20 mg BID v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.003
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.54
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 2.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.515
    Statistical analysis title
    		 Change from Baseline in TMC Score of the UHDRS
    Statistical analysis description
    Baseline, Week 13
    Comparison groups
    PF-02545920 5 mg BID v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4656
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 1.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.491
    Statistical analysis title
    		 Change from Baseline in TMC Score of the UHDRS
    Statistical analysis description
    Baseline, Week 26
    Comparison groups
    PF-02545920 20 mg BID v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0149
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 2.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.492
    Statistical analysis title
    		 Change from Baseline in TMC Score of the UHDRS
    Statistical analysis description
    Baseline, Week 26
    Comparison groups
    PF-02545920 5 mg BID v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8233
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.66
         upper limit
    		 0.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.46

    Secondary: Number of Subjects with Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) from Baseline to Follow-up Visit

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    End point title
    		 Number of Subjects with Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) from Baseline to Follow-up Visit
    End point description
    The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether subject experienced following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of subjects with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
    End point type
    Secondary
    End point timeframe
    Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    87
    95
    88
    Units: subjects
        Completed Suicide
    0
    0
    0
        Suicide Attempt
    1
    0
    0
        Imminent Suicidal Behavior
    1
    1
    0
        Suicidal Ideation
    7
    5
    4
        Self-Injurious Behavior, No Suicidal Attempt
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.

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    End point title
    		 Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.
    End point description
    CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: “Compared to your subject’s condition at the beginning of treatment, how much has your subject changed?”. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. n is the number of evaluable subjects in each visit.
    End point type
    Secondary
    End point timeframe
    Week 13 & Week 26
    End point values
    		 PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
    Number of subjects analysed
    84
    95
    88
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 13 (n= 66, 83, 77)
    4 ± 1
    3.7 ± 0.9
    3.6 ± 0.83
        Week 26 (n=59, 83, 80)
    3.9 ± 1.13
    3.8 ± 0.99
    3.8 ± 0.91
    Statistical analysis title
    		 CGI-I Scale Score
    Statistical analysis description
    Week 13
    Comparison groups
    PF-02545920 20 mg BID v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0181
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.148
    Statistical analysis title
    		 CGI-I Scale Score
    Statistical analysis description
    Week 13
    Comparison groups
    PF-02545920 5 mg BID v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7133
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 CGI-I Scale Score
    Statistical analysis description
    Week 26
    Comparison groups
    PF-02545920 20 mg BID v Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.4657
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.163
    Statistical analysis title
    		 CGI-I Scale Score
    Statistical analysis description
    Week 26
    Comparison groups
    PF-02545920 5 mg BID v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8339
    Method
    		 MMRM
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one 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
    19.1
    Reporting groups
    Reporting group title
    PF-02545920 5 mg BID
    Reporting group description
    		 Subjects took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Reporting group title
    PF-02545920 20 mg BID
    Reporting group description
    		 The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Subjects took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.

    Serious adverse events
    		 PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 95 (2.11%)
    7 / 88 (7.95%)
    8 / 87 (9.20%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 88 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vestibular migraine
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 88 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    2 / 87 (2.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 95 (0.00%)
    0 / 88 (0.00%)
    1 / 87 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 95 (74.74%)
    42 / 88 (47.73%)
    65 / 87 (74.71%)
    Investigations
    Weight decreased
         subjects affected / exposed
    6 / 95 (6.32%)
    1 / 88 (1.14%)
    15 / 87 (17.24%)
         occurrences all number
    6
    1
    16
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    15 / 95 (15.79%)
    9 / 88 (10.23%)
    5 / 87 (5.75%)
         occurrences all number
    30
    16
    10
    Nervous system disorders
    Chorea
         subjects affected / exposed
    4 / 95 (4.21%)
    1 / 88 (1.14%)
    8 / 87 (9.20%)
         occurrences all number
    4
    1
    9
    Dizziness
         subjects affected / exposed
    1 / 95 (1.05%)
    4 / 88 (4.55%)
    10 / 87 (11.49%)
         occurrences all number
    1
    5
    13
    Dyskinesia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 88 (1.14%)
    9 / 87 (10.34%)
         occurrences all number
    0
    1
    12
    Headache
         subjects affected / exposed
    8 / 95 (8.42%)
    8 / 88 (9.09%)
    8 / 87 (9.20%)
         occurrences all number
    10
    15
    15
    Sedation
         subjects affected / exposed
    5 / 95 (5.26%)
    0 / 88 (0.00%)
    2 / 87 (2.30%)
         occurrences all number
    6
    0
    2
    Somnolence
         subjects affected / exposed
    9 / 95 (9.47%)
    3 / 88 (3.41%)
    16 / 87 (18.39%)
         occurrences all number
    12
    3
    20
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 95 (11.58%)
    9 / 88 (10.23%)
    16 / 87 (18.39%)
         occurrences all number
    11
    11
    20
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 95 (7.37%)
    6 / 88 (6.82%)
    7 / 87 (8.05%)
         occurrences all number
    7
    7
    10
    Dry mouth
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 88 (0.00%)
    6 / 87 (6.90%)
         occurrences all number
    1
    0
    6
    Nausea
         subjects affected / exposed
    12 / 95 (12.63%)
    7 / 88 (7.95%)
    11 / 87 (12.64%)
         occurrences all number
    14
    8
    16
    Vomiting
         subjects affected / exposed
    10 / 95 (10.53%)
    3 / 88 (3.41%)
    7 / 87 (8.05%)
         occurrences all number
    12
    3
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    6 / 95 (6.32%)
    2 / 88 (2.27%)
    12 / 87 (13.79%)
         occurrences all number
    7
    3
    18
    Insomnia
         subjects affected / exposed
    4 / 95 (4.21%)
    2 / 88 (2.27%)
    11 / 87 (12.64%)
         occurrences all number
    4
    3
    12
    Irritability
         subjects affected / exposed
    7 / 95 (7.37%)
    1 / 88 (1.14%)
    1 / 87 (1.15%)
         occurrences all number
    7
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 95 (3.16%)
    5 / 88 (5.68%)
    2 / 87 (2.30%)
         occurrences all number
    3
    6
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    18 / 95 (18.95%)
    12 / 88 (13.64%)
    8 / 87 (9.20%)
         occurrences all number
    25
    13
    9
    Urinary tract infection
         subjects affected / exposed
    5 / 95 (5.26%)
    3 / 88 (3.41%)
    4 / 87 (4.60%)
         occurrences all number
    6
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported
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