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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Proportion of patients seizure-free for 6 months during the efficacy assessment phase (excluding dose escalation phase).
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Sleep Scale
  • Time Frame: over 52 weeks
    Safety Issue?: No
• Seizure freedom by month and by avg. daily dose
  • Time Frame: monthly
    Safety Issue?: No
• Anxiety and Depression Scale
  • Time Frame: over 52 weeks
    Safety Issue?: No
• Time to 6-month seizure-freedom
  • Time Frame: within 52 weeks
    Safety Issue?: No
• Time to 1st seizure
  • Time Frame: within 52 weeks
    Safety Issue?: No
• Time to exit due to adverse event, lack of efficacy, or any reason
  • Time Frame: within 52 weeks
    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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on September 04, 2008

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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