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Trial record 4 of 183 for:    "huntington disease"

Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease

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ClinicalTrials.gov Identifier: NCT02197130
Recruitment Status : Completed
First Posted : July 22, 2014
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Huntington's Disease
Interventions Drug: PF-02545920
Other: Placebo
Enrollment 272
Recruitment Details  
Pre-assignment Details A total of 272 subjects (133 males and 139 females) were randomized and assigned study treatment.
Arm/Group Title PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID
Hide Arm/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. 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. 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.
Period Title: Overall Study
Started 95 89 88
Received Treatment 95 88 87
Completed 79 81 56
Not Completed 16 8 32
Reason Not Completed
Adverse Event             13             4             23
Death             0             1             0
Lost to Follow-up             2             0             1
Does not meet entrance criteria             0             0             1
Withdrawal by Subject             0             3             4
Other             1             0             3
Arm/Group Title PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID Total
Hide Arm/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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 95 88 87 270
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 88 participants 87 participants 270 participants
48.3  (8.6) 50.2  (9.4) 48.4  (9.2) 48.9  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 88 participants 87 participants 270 participants
Female
42
  44.2%
54
  61.4%
43
  49.4%
139
  51.5%
Male
53
  55.8%
34
  38.6%
44
  50.6%
131
  48.5%
1.Primary Outcome
Title Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.
Hide 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 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 was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 59 83 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (8.63) -0.8  (7.30) -1.4  (6.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-02545920 20 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2033
Comments [Not Specified]
Method MMRM
Comments MMRM: A linear mixed‑effect repeated measures model
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.52
Confidence Interval (2-Sided) 90%
-0.45 to 3.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.192
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7549
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.35
Confidence Interval (2-Sided) 90%
-2.20 to 1.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.118
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria
Hide 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
Time Frame Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: participants
Criterion A 0 1 0
Criterion B 0 0 0
Criterion C 0 0 0
Criterion D 0 0 0
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: participants
76 82 63
4.Secondary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description Adverse event (AE) was any untoward medical occurrence in a participant 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.
Time Frame Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: participants
8 2 7
5.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)
Hide 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).
Time Frame Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 86 95 88
Measure Type: Number
Unit of Measure: participants
47 46 48
6.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)
Hide 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).
Time Frame Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 86 95 88
Measure Type: Number
Unit of Measure: participants
40 36 41
7.Secondary Outcome
Title Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)
Hide 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;
Time Frame Screening, Day 1, 28, 91, and 182
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: participants
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
8.Secondary Outcome
Title Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)
Hide 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
Time Frame Screening, Day 1, 28, 91, and 182
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: participants
Criterion A 4 1 4
Criterion B 7 8 6
Criterion C 3 3 10
Criterion D 3 8 9
9.Secondary Outcome
Title Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)
Hide Description The number of participants 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
Time Frame Screening, Day 1, 28, 91, and 182
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: participants
Criterion A 1 7 3
Criterion B 9 8 9
Criterion C 8 6 8
Criterion D 10 14 9
10.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)
Hide Description The number of participants 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
Time Frame Screening, Day 1, 28, 91, and 182
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 86 93 88
Measure Type: Number
Unit of Measure: participants
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
11.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)
Hide Description Number of participants 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.
Time Frame Screening, Day 1, 28, 91, and 182
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 86 93 88
Measure Type: Number
Unit of Measure: participants
Criterion A 0 0 0
Criterion B 0 0 0
Criterion C 4 4 6
Criterion D 1 0 0
12.Secondary Outcome
Title Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia
Hide Description Adverse event (AE) was any untoward medical occurrence in a participant 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.
Time Frame Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: 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
13.Secondary Outcome
Title Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.
Hide 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). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. n is the number of evaluable subjects in each visit.
Time Frame Baseline, Week 13, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 84 95 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 13 Number Analyzed 67 participants 83 participants 77 participants
1.1  (3.92) -0.2  (3.50) -0.9  (2.56)
Week 26 Number Analyzed 59 participants 83 participants 80 participants
0.7  (3.81) -0.4  (2.84) -0.8  (2.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-02545920 20 mg BID, Placebo
Comments Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.54
Confidence Interval (2-Sided) 90%
0.69 to 2.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.515
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg BID, Placebo
Comments Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4656
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.36
Confidence Interval (2-Sided) 90%
-0.45 to 1.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.491
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-02545920 20 mg BID, Placebo
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.21
Confidence Interval (2-Sided) 90%
0.39 to 2.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.492
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg BID, Placebo
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8233
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.66 to 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.460
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit
Hide Description The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether participant 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 participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Time Frame Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with at least one dose of study medication.n is the number of evaluable participants in each visit
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 87 95 88
Measure Type: Number
Unit of Measure: participants
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
15.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.
Hide 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 participants in each visit.
Time Frame Week 13 & Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements will not contribute to the analysis, except in the description of the baseline values.
Arm/Group Title PF-02545920 20 mg BID PF-02545920 5 mg BID Placebo
Hide Arm/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.
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.
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.
Overall Number of Participants Analyzed 84 95 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 13 Number Analyzed 66 participants 83 participants 77 participants
4.0  (1.00) 3.7  (0.90) 3.6  (0.83)
Week 26 Number Analyzed 59 participants 83 participants 80 participants
3.9  (1.13) 3.8  (0.99) 3.8  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-02545920 20 mg BID, Placebo
Comments Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0181
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.35
Confidence Interval (2-Sided) 90%
0.11 to 0.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.148
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg BID, Placebo
Comments Week 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7133
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-0.18 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.140
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-02545920 20 mg BID, Placebo
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4657
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-0.15 to 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.163
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg BID, Placebo
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8339
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.22 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.150
Estimation Comments [Not Specified]
Time Frame Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
Adverse Event Reporting 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 participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID
Hide Arm/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. 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. 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.
All-Cause Mortality
PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/95 (2.11%)   7/88 (7.95%)   8/87 (9.20%) 
Cardiac disorders       
Atrial fibrillation * 1  1/95 (1.05%)  0/88 (0.00%)  0/87 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
General disorders       
General physical health deterioration * 1  0/95 (0.00%)  0/88 (0.00%)  2/87 (2.30%) 
Infections and infestations       
Clostridium difficile colitis * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Pneumonia * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Urinary tract infection * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Injury, poisoning and procedural complications       
Fall * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Head injury * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Rib fracture * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Investigations       
Weight decreased * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic carcinoma * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Nervous system disorders       
Syncope * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Vestibular migraine * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Product Issues       
Device occlusion * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Psychiatric disorders       
Acute stress disorder * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
Agitation * 1  1/95 (1.05%)  0/88 (0.00%)  0/87 (0.00%) 
Anxiety * 1  1/95 (1.05%)  1/88 (1.14%)  0/87 (0.00%) 
Major depression * 1  0/95 (0.00%)  0/88 (0.00%)  2/87 (2.30%) 
Suicidal behaviour * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Suicidal ideation * 1  0/95 (0.00%)  1/88 (1.14%)  1/87 (1.15%) 
Suicide attempt * 1  0/95 (0.00%)  0/88 (0.00%)  1/87 (1.15%) 
Respiratory, thoracic and mediastinal disorders       
Asphyxia * 1  0/95 (0.00%)  1/88 (1.14%)  0/87 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-02545920 5 mg BID Placebo PF-02545920 20 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   71/95 (74.74%)   42/88 (47.73%)   65/87 (74.71%) 
Gastrointestinal disorders       
Diarrhoea * 1  7/95 (7.37%)  6/88 (6.82%)  7/87 (8.05%) 
Dry mouth * 1  1/95 (1.05%)  0/88 (0.00%)  6/87 (6.90%) 
Nausea * 1  12/95 (12.63%)  7/88 (7.95%)  11/87 (12.64%) 
Vomiting * 1  10/95 (10.53%)  3/88 (3.41%)  7/87 (8.05%) 
General disorders       
Fatigue * 1  11/95 (11.58%)  9/88 (10.23%)  16/87 (18.39%) 
Infections and infestations       
Nasopharyngitis * 1  18/95 (18.95%)  12/88 (13.64%)  8/87 (9.20%) 
Urinary tract infection * 1  5/95 (5.26%)  3/88 (3.41%)  4/87 (4.60%) 
Injury, poisoning and procedural complications       
Fall * 1  15/95 (15.79%)  9/88 (10.23%)  5/87 (5.75%) 
Investigations       
Weight decreased * 1  6/95 (6.32%)  1/88 (1.14%)  15/87 (17.24%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  3/95 (3.16%)  5/88 (5.68%)  2/87 (2.30%) 
Nervous system disorders       
Chorea * 1  4/95 (4.21%)  1/88 (1.14%)  8/87 (9.20%) 
Dizziness * 1  1/95 (1.05%)  4/88 (4.55%)  10/87 (11.49%) 
Dyskinesia * 1  0/95 (0.00%)  1/88 (1.14%)  9/87 (10.34%) 
Headache * 1  8/95 (8.42%)  8/88 (9.09%)  8/87 (9.20%) 
Sedation * 1  5/95 (5.26%)  0/88 (0.00%)  2/87 (2.30%) 
Somnolence * 1  9/95 (9.47%)  3/88 (3.41%)  16/87 (18.39%) 
Psychiatric disorders       
Anxiety * 1  6/95 (6.32%)  2/88 (2.27%)  12/87 (13.79%) 
Insomnia * 1  4/95 (4.21%)  2/88 (2.27%)  11/87 (12.64%) 
Irritability * 1  7/95 (7.37%)  1/88 (1.14%)  1/87 (1.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 18007181021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02197130     History of Changes
Other Study ID Numbers: A8241021
2014-001291-56 ( EudraCT Number )
First Submitted: July 16, 2014
First Posted: July 22, 2014
Results First Submitted: September 7, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017