Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial (PREPS MEXICO)

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00407797
First received: December 1, 2006
Last updated: February 4, 2011
Last verified: February 2011
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Partial Seizures
Intervention: Drug: Pregabalin

  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
A total of 152 subjects were screened and 136 subjects were assigned to study treatment.

Reporting Groups
  Description
Pregabalin 150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability

Participant Flow:   Overall Study
    Pregabalin  
STARTED     136  
Full Analysis Set     135 [1]
COMPLETED     118  
NOT COMPLETED     18  
Lost to Follow-up                 2  
Adverse Event                 6  
Unspecified                 7  
Withdrawal by Subject                 3  
[1] At least 1 dose of study medication and had a baseline and at least 1 post-baseline measurement.



  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 per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  136  
Age, Customized  
[units: participants]
 
18 - 44 years     107  
45 - 64 years     25  
>= 65 years     4  
Gender  
[units: participants]
 
Female     76  
Male     60  
28-Day Seizure Rate [1]
[units: seizure rate]
Mean ± Standard Deviation
  7.8  ± 14.0  
28 day seizure frequency in Subjects with <= 6 and > 6 seizures during Baseline Period [2]
[units: seizures]
Mean ± Standard Deviation
 
<=6 seizures     2  ± 0.8  
> 6 seizures     12  ± 17.2  
Medical Outcomes Study Sleep Scale [3]
[units: scores on scale]
Mean ± Standard Deviation
 
Sleep Disturbance     32.9  ± 20.9  
Snoring     40.1  ± 33.4  
Awaken Short of Breath     26.0  ± 24.8  
Quantity of Sleep     7.9  ± 1.9  
Optimal Sleep     0.5  ± 0.5  
Sleep Adequacy     64.6  ± 26.1  
Somnolence     39.2  ± 24.5  
9-Item Sleep Problems Index     33.4  ± 15.8  
Hospital Anxiety and Depression Scale (HADS) [4]
[units: score on scale]
Mean ± Standard Deviation
 
Anxiety Total Score     8.8  ± 4.2  
Depression Total Score     7.3  ± 4.1  
[1] Number of partial seizures in baseline period divided by duration of period based on observed visit dates multiplied by 28.
[2] Baseline period = 8 week period before Visit 1 date, including any unplanned readings falling under this period.
[3] Subject rated questionnaire to assess sleep quality and quantity. For 5 of 7 subscales transformed total score range = 0 to 100; other subscales: Sleep Quantity range: 0-24 hours; and Optimal Sleep range: 1 (optimal sleep: quantity 7 or 8 hours per night), or 0 (no optimal sleep). Higher score indicates greater intensity or quantity of attribute.
[4] HADS-A: generalized anxiety; HADS-D: lost interest and diminished pleasure response (lowering of hedonic tone). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase   [ Time Frame: Week 9 to Week 21 or End of Treatment (early termination) ]

2.  Secondary:   Response Ratio (RR)   [ Time Frame: Week 9 to Week 21 or End of Treatment (early termination) ]

3.  Secondary:   Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21   [ Time Frame: Week 21 or End of Treatment (early termination) ]

4.  Secondary:   Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period   [ Time Frame: Week 9 to Week 21 or End of Treatment (early termination) ]

5.  Secondary:   Percent of Seizure- Free Participants During the Treatment Observation Period   [ Time Frame: Week 9 to Week 21 or Early Termination (end of treatment) ]

6.  Secondary:   Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period   [ Time Frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) ]

7.  Secondary:   Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period   [ Time Frame: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9) ]

8.  Secondary:   Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period   [ Time Frame: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9) ]

9.  Secondary:   Treatment Satisfaction: Patient General Impression to Change (PGIC)   [ Time Frame: Week 21, LOCF ]

10.  Secondary:   Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)   [ Time Frame: Week 21, LOCF ]

11.  Secondary:   Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale   [ Time Frame: Week 21, LOCF ]

12.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Week 21, LOCF ]


  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
No text entered.


  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: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00407797     History of Changes
Other Study ID Numbers: A0081090
Study First Received: December 1, 2006
Results First Received: August 12, 2010
Last Updated: February 4, 2011
Health Authority: Mexico: Federal Commission for Protection Against Health Risks