Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy - Study Results

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:	Epilepsy, Partial
Interventions:	Drug: Pregabalin Drug: Lamotrigine

Participant Flow

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	Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
Lamotrigine	Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.

Participant Flow for 2 periods

Period 1: Efficacy Assessment Phase

	Pregabalin	Lamotrigine
STARTED	330	330
COMPLETED	236 ^[1]	250 ^[1]
NOT COMPLETED	94	80
Death	2	0
Adverse Event	33	31
Laboratory abnormaility	1	0
Lack of Efficacy	19	3
Lost to Follow-up	6	13
Unspecified	7	8
Withdrawal by Subject	26	25

[1]	Week 56: up to end of efficacy assessment phase (excluding extension phase).

Period 2: Extension Phase

	Pregabalin	Lamotrigine
STARTED	194 ^[1]	215 ^[1]
COMPLETED	145	177
NOT COMPLETED	49	38

[1]	Optional phase; number entered was less than the number who completed the efficacy assessment phase.

Baseline Characteristics

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Reporting Groups

	Description
Pregabalin	Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
Lamotrigine	Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.

Baseline Measures

	Pregabalin	Lamotrigine	Total
Number of Participants [units: participants]	330	330	660
Age, Customized [units: participants]
< 18 years	9	9	18
Between 18 and 44 years	228	228	456
Between 45 and 64 years	79	74	153
>= 65 years	14	19	33
Gender [units: participants]
Female	165	146	311
Male	165	184	349

Outcome Measures

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1. Primary:

Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase [ Time Frame: Week 5 up to Week 56 ]

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2. Secondary:

Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures [ Time Frame: Week 4 up to Week 56 ]

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3. Secondary:

Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) [ Time Frame: Week 0 to Week 56 ]

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4. Secondary:

Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) [ Time Frame: Week 0 to Week 56 ]

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5. Secondary:

Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase [ Time Frame: Week 4 up to Week 56 ]

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6. Secondary:

Exit Due to Any Reason After 4-week Dose Escalation Phase [ Time Frame: Week 4 up to Week 56 ]

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7. Secondary:

Time to First Seizure After the 4-Week Dose Escalation Phase [ Time Frame: Week 4 up to Week 56 ]

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8. Secondary:

Median Monthy Seizure Frequency: All Partial Seizures [ Time Frame: Baseline up to Week 60 ]

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9. Secondary:

Mean Monthy Seizure Frequency: All Partial Seizures [ Time Frame: Baseline up to Week 60 ]

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10. Secondary:

Median Monthy Seizure Frequency: All Seizures [ Time Frame: Baseline up to Week 60 ]

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11. Secondary:

Mean Monthy Seizure Frequency: All Seizures [ Time Frame: Baseline up to Week 60 ]

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12. Secondary:

Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ]

Show Outcome Measure 12

13. Secondary:

Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ]

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14. Secondary:

Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ]

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15. Secondary:

Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ]

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16. Secondary:

Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group [ Time Frame: Week 5 up to Week 56 ]

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17. Secondary:

Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to Week 56 ]

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18. Secondary:

Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale [ Time Frame: Week 8, Week 32, and Week 56 ]

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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
Cox proportional hazards model for time to event (TTE) analyses; three summary statistics were not generated as median TTE will not exist if survival function (Kaplan-Meier product limit estimates) does not fall below 0.5 (post-hoc analysis).

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:	NCT00280059 History of Changes
Other Study ID Numbers:	A0081046
Study First Received:	January 18, 2006
Results First Received:	December 16, 2010
Last Updated:	October 20, 2011
Health Authority:	United Kingdom: European Medicines Agency