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Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021

Primary Purpose

Huntington's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
20 mg BID of PF-02545920
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington's Disease focused on measuring Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms

Eligibility Criteria

30 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have completed study A8241021
  • Diagnosis of HD, including ≥36 CAG repeats.

Exclusion Criteria:

  • Significant neurological disorder other than Huntington's disease.
  • WBC ≤ 3500/mm3 AND/OR ANC ≤ 2000/mm3 and history of neutropenia or myeolo-proliferative disorders.
  • Any drug related SAE experienced during study A8241021 which were not approved as acceptable for enrollment in A8241022.

Sites / Locations

  • The Kirkland Clinic of UAB Hospital
  • University of Alabama at Birmingham
  • Mayo Clinic Arizona
  • University of California, Irvine
  • Ronald Reagan UCLA Medical Center Drug Information Center
  • UCLA Neurology Clinic
  • UCLA Radiology
  • Rocky Mountain Movement Disorders Center
  • University of Florida Center for Movement Disorders & Neurorestoration
  • Indiana University Health Neuroscience Center
  • Washington University School of Medicine
  • Albany Medical College
  • Wake Forest Baptist Medical Center
  • The Ohio State University
  • The Wexner Medical Center at the Ohio State University
  • The Wright Center of Innovation- The Ohio State University
  • Baylor College of Medicine
  • The Centre For Huntington Disease, The University of British Columbia
  • Center For Movement Disorders
  • CHUM-Notre-Dame Hospital
  • CHUM-Notre-Dame, Pharmacie
  • Uniklinik RWTH Aachen
  • Charité - Universitätsmedizin Berlin
  • St. Josef Hospital
  • Friedrich-Alexander-Universität
  • Universität zu Lübeck
  • Philipps Universitat Marburg
  • Technische Universität München
  • George-Huntington-Institut
  • Kbo-Isar-Amper-Klinikum gGmbH
  • Universitätsklinikum Ulm
  • Universitaetsklinikum Wuerzburg
  • Copernicus Podmiot Leczniczy sp.zo.o
  • Krakowska Akademia Neurologii Sp. zo.o
  • Solumed Centrum Medyczne
  • Instytut Psychiatrii i Neurologii, I Klinika Neurologiczna
  • Central Manchester University Hospitals NHS Foundation Trust
  • St Nicholas Hospital
  • Bimingham & Solihull Mental Health NHS Foundation Trust Department of Neuropsychiatry
  • NHS Grampian, Aberdeen Royal Infirmary, Clinical Genetics Centre
  • Institute of Psychological Medicine and Clinical Neurosciences
  • NHS Greater Glasgow and Clyde
  • Guy's and St. Thomas' NHS Foundation Trust
  • University College London Hospitals Huntington's Diesease
  • University College London Hospitals NHS Foundation Trust
  • The National Institute for Health Research / Wellcome Trust Clinical Research Facility
  • Newcastle Magnetic Resonance Centre
  • Oxford University Hospitals NHS Trust
  • Sheffield Teaching Hospital NHS Foundation Trust
  • University Hospital Southampton NHS Foundation Trust, Wessex Neurological Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

20 mg BID PF-02545920 non-titrated

20mg BID PF-02545920 titrated

Arm Description

Subjects who received 20 mg BID in completed study A8241021 will continue to receive 20 mg BID PF-02545920

Subjects who received either Placebo or 5mg BID of PF-02545920 in completed study A8241021 will be titrated up to 20 mg with 5mg increment per week, over 4 weeks (5mg increment/wk)

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. 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; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study treatment and up to 28 calendar days after the last administration of study treatment that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Number of participants with vital signs data meeting the following criteria is presented: (1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); (2) standing SBP <90 mmHg; (3) supine diastolic blood pressure (DBP) <50 mmHg; (4) standing DBP <50 mmHg; (5) supine pulse rate <40 beats per minute (bpm); (6) supine pulse rate >120 bpm; (7) standing pulse rate <40 bpm; (8) standing pulse rate >140 bpm; (9) maximum increase from baseline in supine SBP >= 30 mmHg; (10) maximum increase from baseline in standing SBP >= 30 mmHg; (11) maximum increase from baseline in supine DBP >= 20 mmHg; (12) maximum increase from baseline in standing DBP >= 20 mmHg; (13) maximum decrease from baseline in supine SBP >=30 mmHg; (14) maximum decrease from baseline in standing SBP >=30 mmHg; (15) maximum decrease from baseline in supine DBP >=20 mmHg; (16) maximum decrease from baseline in standing DBP >=20 mmHg.
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
Maximum absolute values and increases from baseline were summarized for PR interval (interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of the S wave corresponding to ventricular depolarization), and QTcF interval (time from ECG Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula). Number of participants with ECG data meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=140 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval increase from baseline >=25/50 percent; (7) QRS complex increase from baseline >=50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.
Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality)
Number of participants with white blood cell (WBC) count and absolute neutrophil count (ANC) meeting the following criteria is presented: (1) WBC count <0.6 *the lower limit of normal (LLN); (2) WBC count >1.5 times the upper limit of normal (ULN); (3) ANC <0.8*LLN; and (4) ANC >1.2*ULN.
Number of Participants With Laboratory Test Abnormalities (Normal Baseline)
The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity
Adverse events related to extrapyramidal symptoms included dystonia, akathisia, tardive dyskinesia). Severity was assessed by the investigator. Mild means the AE didn't interfere with the participant's usual function. Moderate means the AE interfered to some extent the participant's usual function. Severe means the AE interfered significantly with the participant's usual function.
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category
Columbia Suicide Severity Rating Scale (C-SSRS) was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior, and was used in this study. C-SSRS responses were mapped onto the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Number of participants with any of the following behaviors occurring since last visit was summarized: completed suicide; suicide attempt; preparatory acts towards suicide; suicidal ideation; self-injurious behavior (no suicidal intent).

Secondary Outcome Measures

Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score
The UHDRS is a clinical rating scale developed 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. Total Motor Score (TMS) assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural ability. 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.
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score
The UHDRS is a clinical rating scale developed 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. Total Maximum Chorea (TMC) is a subset of the TMS assessment, and composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment is 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.
Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score
The Clinical Global Impression of Improvement (CGI-I) is a global measure of improvement or change based on the clinician's assessment of all available clinical data obtained from interviewing the participant. The CGI-I consists of a single 7-point rating of total improvement or change from baseline severity, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, "Compared to your participant's condition at the beginning of treatment, how much has he/she changed?" Scores are: 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse.

Full Information

First Posted
January 15, 2015
Last Updated
March 23, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02342548
Brief Title
Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021
Official Title
An Open Label Extension Study To Investigate The Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Previously Completed Study A8241021
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Study terminated on 15DEC2016 due to study A8241021 showing no significant difference on primary endpoint between PF-02545920 & placebo. No safety concerns.
Study Start Date
February 25, 2015 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
February 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will be titrated to the 20 mg BID dose 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. Up to 260 subjects may take part in this open label extension

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
Keywords
Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 mg BID PF-02545920 non-titrated
Arm Type
Experimental
Arm Description
Subjects who received 20 mg BID in completed study A8241021 will continue to receive 20 mg BID PF-02545920
Arm Title
20mg BID PF-02545920 titrated
Arm Type
Experimental
Arm Description
Subjects who received either Placebo or 5mg BID of PF-02545920 in completed study A8241021 will be titrated up to 20 mg with 5mg increment per week, over 4 weeks (5mg increment/wk)
Intervention Type
Drug
Intervention Name(s)
20 mg BID of PF-02545920
Intervention Description
All subject who completed A8241021 will receive 20 mg BID (with or without titration)
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. 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; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study treatment and up to 28 calendar days after the last administration of study treatment that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.
Time Frame
1 year
Title
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Description
The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.
Time Frame
1 year
Title
Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria
Description
Number of participants with vital signs data meeting the following criteria is presented: (1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); (2) standing SBP <90 mmHg; (3) supine diastolic blood pressure (DBP) <50 mmHg; (4) standing DBP <50 mmHg; (5) supine pulse rate <40 beats per minute (bpm); (6) supine pulse rate >120 bpm; (7) standing pulse rate <40 bpm; (8) standing pulse rate >140 bpm; (9) maximum increase from baseline in supine SBP >= 30 mmHg; (10) maximum increase from baseline in standing SBP >= 30 mmHg; (11) maximum increase from baseline in supine DBP >= 20 mmHg; (12) maximum increase from baseline in standing DBP >= 20 mmHg; (13) maximum decrease from baseline in supine SBP >=30 mmHg; (14) maximum decrease from baseline in standing SBP >=30 mmHg; (15) maximum decrease from baseline in supine DBP >=20 mmHg; (16) maximum decrease from baseline in standing DBP >=20 mmHg.
Time Frame
1 year
Title
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria
Description
Maximum absolute values and increases from baseline were summarized for PR interval (interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of the S wave corresponding to ventricular depolarization), and QTcF interval (time from ECG Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula). Number of participants with ECG data meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=140 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval increase from baseline >=25/50 percent; (7) QRS complex increase from baseline >=50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.
Time Frame
1 year
Title
Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality)
Description
Number of participants with white blood cell (WBC) count and absolute neutrophil count (ANC) meeting the following criteria is presented: (1) WBC count <0.6 *the lower limit of normal (LLN); (2) WBC count >1.5 times the upper limit of normal (ULN); (3) ANC <0.8*LLN; and (4) ANC >1.2*ULN.
Time Frame
1 year
Title
Number of Participants With Laboratory Test Abnormalities (Normal Baseline)
Description
The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.
Time Frame
1 year
Title
Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity
Description
Adverse events related to extrapyramidal symptoms included dystonia, akathisia, tardive dyskinesia). Severity was assessed by the investigator. Mild means the AE didn't interfere with the participant's usual function. Moderate means the AE interfered to some extent the participant's usual function. Severe means the AE interfered significantly with the participant's usual function.
Time Frame
1 year
Title
Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category
Description
Columbia Suicide Severity Rating Scale (C-SSRS) was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior, and was used in this study. C-SSRS responses were mapped onto the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Number of participants with any of the following behaviors occurring since last visit was summarized: completed suicide; suicide attempt; preparatory acts towards suicide; suicidal ideation; self-injurious behavior (no suicidal intent).
Time Frame
Baseline (Day 1), Weeks 2 and 4, Months 3, 6, 9 and 12, follow-up visit (7-14 days after the last dose of Month 12)
Secondary Outcome Measure Information:
Title
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score
Description
The UHDRS is a clinical rating scale developed 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. Total Motor Score (TMS) assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural ability. 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 (Day 1), Month 6, and Month 12
Title
Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score
Description
The UHDRS is a clinical rating scale developed 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. Total Maximum Chorea (TMC) is a subset of the TMS assessment, and composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment is 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.
Time Frame
Baseline (Day 1), Month 6, and Month 12
Title
Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score
Description
The Clinical Global Impression of Improvement (CGI-I) is a global measure of improvement or change based on the clinician's assessment of all available clinical data obtained from interviewing the participant. The CGI-I consists of a single 7-point rating of total improvement or change from baseline severity, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, "Compared to your participant's condition at the beginning of treatment, how much has he/she changed?" Scores are: 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse.
Time Frame
Month 6 and Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have completed study A8241021 Diagnosis of HD, including ≥36 CAG repeats. Exclusion Criteria: Significant neurological disorder other than Huntington's disease. WBC ≤ 3500/mm3 AND/OR ANC ≤ 2000/mm3 and history of neutropenia or myeolo-proliferative disorders. Any drug related SAE experienced during study A8241021 which were not approved as acceptable for enrollment in A8241022.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The Kirkland Clinic of UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center Drug Information Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Neurology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Radiology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Rocky Mountain Movement Disorders Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Florida Center for Movement Disorders & Neurorestoration
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Indiana University Health Neuroscience Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
The Wexner Medical Center at the Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
The Wright Center of Innovation- The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Centre For Huntington Disease, The University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Center For Movement Disorders
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
CHUM-Notre-Dame Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHUM-Notre-Dame, Pharmacie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4L 4M1
Country
Canada
Facility Name
Uniklinik RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
St. Josef Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Friedrich-Alexander-Universität
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universität zu Lübeck
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Philipps Universitat Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Technische Universität München
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
George-Huntington-Institut
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Kbo-Isar-Amper-Klinikum gGmbH
City
Taufkirchen
ZIP/Postal Code
84416
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Copernicus Podmiot Leczniczy sp.zo.o
City
Gdansk
ZIP/Postal Code
80462
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp. zo.o
City
Krakow
ZIP/Postal Code
31505
Country
Poland
Facility Name
Solumed Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii, I Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02957
Country
Poland
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Oxford Road
State/Province
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
St Nicholas Hospital
City
Gosforth
State/Province
Newcastle UPON TYNE
ZIP/Postal Code
NE3 3XT
Country
United Kingdom
Facility Name
Bimingham & Solihull Mental Health NHS Foundation Trust Department of Neuropsychiatry
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B15 2FG
Country
United Kingdom
Facility Name
NHS Grampian, Aberdeen Royal Infirmary, Clinical Genetics Centre
City
Aberdeen
ZIP/Postal Code
AB25 2ZA
Country
United Kingdom
Facility Name
Institute of Psychological Medicine and Clinical Neurosciences
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Guy's and St. Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE19RT
Country
United Kingdom
Facility Name
University College London Hospitals Huntington's Diesease
City
London
ZIP/Postal Code
wc1b 5eh
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
The National Institute for Health Research / Wellcome Trust Clinical Research Facility
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Newcastle Magnetic Resonance Centre
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust, Wessex Neurological Centre
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8241022&StudyName=An%20Open%20Label%20Extension%20Study%20To%20Investigate%20The%20Long%20Term%20Safety%2C%20Tolerability%20And%20Efficacy%20Of%20Pf-02545920%20In%20Subjects%20With%20Huntington%E2%80%99s%20Disease%20Who%20Previously%20Completed%20Study%20A8241021
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021

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