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Trial record 22 of 175 for:    Huntington's Disease

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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ClinicalTrials.gov Identifier: NCT02342548
Recruitment Status : Terminated (Study terminated on 15DEC2016 due to study A8241021 showing no significant difference on primary endpoint between PF-02545920 & placebo. No safety concerns.)
First Posted : January 21, 2015
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Huntington's Disease
Intervention: Drug: 20 mg BID of PF-02545920

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an open-label extension study conducted in participants who had completed study A8241021 (NCT02197130). Treatment assignment was double-blinded from Day 1 to Day 21, and became open-label from Day 22, since all participants began receiving the same dose level from Day 22.

Reporting Groups
  Description
20 mg PF-02545920 Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
5 mg PF-02545920 Titration up to 20 mg Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Placebo and Titration up to 20 mg PF-02545920 Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).

Participant Flow:   Overall Study
    20 mg PF-02545920   5 mg PF-02545920 Titration up to 20 mg   Placebo and Titration up to 20 mg PF-02545920
STARTED   51   71   66 
COMPLETED   17   9   23 
NOT COMPLETED   34   62   43 
Adverse Event                12                17                13 
Lost to Follow-up                0                1                0 
Study terminated by sponsor                20                39                25 
Protocol Violation                0                1                0 
Withdrawal by Subject                1                3                4 
Other                1                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
20 mg PF-02545920 Participants who received PF-02545920 20 mg twice daily (BID) in Study A8241021 continued to receive PF-02545920 20 mg BID for 12 months in this study. Four 5-mg tablets were administered orally each time.
5 mg PF-02545920 Titration up to 20 mg Participants who received PF-02545920 5 mg twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Placebo and Titration up to 20 mg PF-02545920 Participants who received placebo twice daily (BID) in Study A8241021 were administered PF-02545920 orally according to a double-blind titration schedule in this study: 5 mg BID for 7 days (one 5-mg tablet and 3 placebo tablets); 10 mg BID for 7 days (two 5-mg tablets and 2 placebo tablets); 15 mg BID for 7 days (three 5-mg tablets and 1 placebo tablet); 20 mg BID to Month 12 (four 5-mg tablets).
Total Total of all reporting groups

Baseline Measures
   20 mg PF-02545920   5 mg PF-02545920 Titration up to 20 mg   Placebo and Titration up to 20 mg PF-02545920   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   71   66   188 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.2  (9.4)   48.4  (8.6)   51.3  (9.4)   49.9  (9.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      25  49.0%      33  46.5%      43  65.2%      101  53.7% 
Male      26  51.0%      38  53.5%      23  34.8%      87  46.3% 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   50   68   66   184 
Other   1   3   0   4 


  Outcome Measures

1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events   [ Time Frame: 1 year ]

2.  Primary:   Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)   [ Time Frame: 1 year ]

3.  Primary:   Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria   [ Time Frame: 1 year ]

4.  Primary:   Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria   [ Time Frame: 1 year ]

5.  Primary:   Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality)   [ Time Frame: 1 year ]

6.  Primary:   Number of Participants With Laboratory Test Abnormalities (Normal Baseline)   [ Time Frame: 1 year ]

7.  Primary:   Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity   [ Time Frame: 1 year ]

8.  Primary:   Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category   [ 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) ]

9.  Secondary:   Change From Baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Motor Score   [ Time Frame: Baseline (Day 1), Month 6, and Month 12 ]

10.  Secondary:   Change From Baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score   [ Time Frame: Baseline (Day 1), Month 6, and Month 12 ]

11.  Secondary:   Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score   [ Time Frame: Month 6 and Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated on 15 December 2016 due to study A8241021 showing no significant difference on primary endpoint between PF-02545920 and placebo. No safety concerns were associated with this termination.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02342548     History of Changes
Other Study ID Numbers: A8241022
2014-004900-31 ( EudraCT Number )
OPEN LABEL TO A8241021 ( Other Identifier: Alias Study Number )
First Submitted: January 15, 2015
First Posted: January 21, 2015
Results First Submitted: February 2, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018