Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00524030
First received: August 30, 2007
Last updated: May 15, 2012
Last verified: May 2012
Results First Received: April 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Epilepsies, Partial
Interventions: Drug: pregabalin 600 mg/day
Drug: pregabalin 150 mg/day

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
Pregabalin 150 mg/Day Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
Pregabalin 600 mg/Day Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.

Participant Flow:   Overall Study
    Pregabalin 150 mg/Day     Pregabalin 600 mg/Day  
STARTED     32     129  
Completed Double-Blind Treatment Phase     15     70  
Completed Taper/Titration Phase     15     70  
COMPLETED     15     70  
NOT COMPLETED     17     59  
Lack of Efficacy                 10                 24  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 3                 8  
Noncompliance/Investigator discretion                 0                 2  
Protocol Violation                 0                 1  
Pregnancy                 1                 0  
Adverse Event                 3                 21  
Death                 0                 1  



  Baseline Characteristics
  Hide 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
Pregabalin 150 mg/Day Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
Pregabalin 600 mg/Day Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
Total Total of all reporting groups

Baseline Measures
    Pregabalin 150 mg/Day     Pregabalin 600 mg/Day     Total  
Number of Participants  
[units: participants]
  32     129     161  
Age  
[units: years]
Mean ± Standard Deviation
  35.2  ± 12.4     39.9  ± 13.2     39.0  ± 13.2  
Gender  
[units: Participants]
     
Female     18     71     89  
Male     14     58     72  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria   [ Time Frame: Week 2 up to Week 18 ]

2.  Secondary:   Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria   [ Time Frame: Week 2 up to Week 18 ]

3.  Secondary:   Percentage of Participants Completing 20 Weeks of Double-Blind Treatment   [ Time Frame: Randomization up to Week 20 ]

4.  Secondary:   Percentage of Participants Who Met Protocol-Specified Exit Events   [ Time Frame: Week 2 up to Week 18 ]

5.  Secondary:   Mean Time on Pregabalin Monotherapy   [ Time Frame: Week 2 to Week 20 ]

6.  Secondary:   Percentage of Seizure-Free Participants by Study Phase   [ Time Frame: Day 1 up to Day 140 ]

7.  Secondary:   Pregabalin Exposure-Response Analysis   [ Time Frame: Day 126 ]

8.  Secondary:   Pregabalin Population Pharmacokinetics (PK)   [ Time Frame: Baseline up to 20 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
External Data Monitoring Committee (DMC) determined study met criteria to stop early for positive efficacy. Exit rate was the basis for primary analysis and is what is reported here.


  More Information
  Hide 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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00524030     History of Changes
Other Study ID Numbers: A0081047
Study First Received: August 30, 2007
Results First Received: April 11, 2012
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration