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

Official Title: “A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures”

The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

Intervention(s) in this Clinical Trial

• Drug: Pregabalin
  • dose 150-600 mg/day given BID
• Drug: Lamotrigine
  • dose 100-500 mg/day given BID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase
  • Time Frame: Week 5 up to Week 56
    Safety Issue?: No

Secondary Measures

• Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures
  • Time Frame: Week 4 up to Week 56
    Safety Issue?: No
• Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)
  • Time Frame: Week 0 to Week 56
    Safety Issue?: No
• Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)
  • Time Frame: Week 0 to Week 56
    Safety Issue?: No
• Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase
  • Time Frame: Week 4 up to Week 56
    Safety Issue?: No
• Exit Due to Any Reason After 4-week Dose Escalation Phase
  • Time Frame: Week 4 up to Week 56
    Safety Issue?: No
• Time to First Seizure After the 4-Week Dose Escalation Phase
  • Time Frame: Week 4 up to Week 56
    Safety Issue?: No
• Median Monthy Seizure Frequency: All Partial Seizures
  • Time Frame: Baseline up to Week 60
    Safety Issue?: No
• Mean Monthy Seizure Frequency: All Partial Seizures
  • Time Frame: Baseline up to Week 60
    Safety Issue?: No
• Median Monthy Seizure Frequency: All Seizures
  • Time Frame: Baseline up to Week 60
    Safety Issue?: No
• Mean Monthy Seizure Frequency: All Seizures
  • Time Frame: Baseline up to Week 60
    Safety Issue?: No
• 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)
    Safety Issue?: No
• 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)
    Safety Issue?: No
• 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)
    Safety Issue?: No
• 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)
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)
  • Time Frame: Baseline to Week 56
    Safety Issue?: No
• Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale
  • Time Frame: Week 8, Week 32, and Week 56
    Safety Issue?: No

Inclusion Criteria:

• Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.

Exclusion Criteria:

• Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin.
• Primary generalized seizures.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00280059

Study ID Number: A0081046

ClinicalTrials.gov Identifier: NCT00280059

Health Authority: United Kingdom: European Medicines Agency

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