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

History of Changes

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

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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
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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

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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

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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 ]

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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 ]

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

Pregabalin Population Pharmacokinetics (PK) [ Time Frame: Baseline up to 20 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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
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.

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

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