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

Tracking Information

First Received Date ^ICMJE

January 18, 2006

Last Updated Date

March 5, 2010

Start Date ^ICMJE

August 2006

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of patients seizure-free for 6 months during the efficacy assessment phase (excluding dose escalation phase). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Proportion of patients seizure-free for 6 months during the efficacy assessment phase (excluding dose escalation phase).

Change History

Complete list of historical versions of study NCT00280059 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep Scale [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
Seizure freedom by month and by avg. daily dose [ Time Frame: monthly ] [ Designated as safety issue: No ]
Anxiety and Depression Scale [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
Time to 6-month seizure-freedom [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]
Time to 1st seizure [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]
Time to exit due to adverse event, lack of efficacy, or any reason [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Time to exit due to adverse events during the double-blind treatment period (including dose escalation phase). Time to 6-months seizure-freedom after the dose escalation phase. Time to exit due to lack of efficacy after the dose escalation phase. Time to

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Epilepsy, Partial

Intervention ^ICMJE

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

Study Arms / Comparison Groups

1: Experimental
Intervention: Drug: Pregabalin
2: Active Comparator
Intervention: Drug: Lamotrigine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

626

Estimated Completion Date

March 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

Belgium, Bulgaria, China, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Portugal, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00280059

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0081046

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP