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

History of Changes

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

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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

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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

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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) ]

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2. Secondary:

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

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

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.

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

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