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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Partial

Intervention: Pregabalin (Drug); Lamotrigine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

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

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

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

Secondary outcome:

Sleep Scale

Seizure freedom by month and by avg. daily dose

Anxiety and Depression Scale

Time to 6-month seizure-freedom

Time to 1st seizure

Time to exit due to adverse event, lack of efficacy, or any reason

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Leuven 3000, Belgium; Active, not recruiting

Pfizer Investigational Site, Brugge 8000, Belgium; Completed

Pfizer Investigational Site, Bruxelles 1070, Belgium; Active, not recruiting

Pfizer Investigational Site, Sofia 1113, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1524, Bulgaria; Recruiting

Pfizer Investigational Site, Plovdiv 4000, Bulgaria; Recruiting

Pfizer Investigational Site, Varna 9010, Bulgaria; Recruiting

Pfizer Investigational Site, Sofia 1309, Bulgaria; Recruiting

Pfizer Investigational Site, Cheng Du Si Chaun 610041, China; Active, not recruiting

Pfizer Investigational Site, Tian Jin 300052, China; Active, not recruiting

Pfizer Investigational Site, Chongqing 400016, China; Active, not recruiting

Pfizer Investigational Site, Ostrava 708 58, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Praha 4 140 59, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Hradec Kralove 500 05, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Pelhrimov 393 01, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Brno 2 602 00, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Rychnov nad Kneznou 516 01, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Tartu 51014, Estonia; Recruiting

Pfizer Investigational Site, Tallinn 10138, Estonia; Completed

Pfizer Investigational Site, Kuopio 70210, Finland; Active, not recruiting

Pfizer Investigational Site, Tampere 33520, Finland; Active, not recruiting

Pfizer Investigational Site, NANCY CEDEX 54035, France; Active, not recruiting

Pfizer Investigational Site, Strasbourg Cedex 67091, France; Active, not recruiting

Pfizer Investigational Site, BORDEAUX CEDEX 33076, France; Active, not recruiting

Pfizer Investigational Site, Bonn 53105, Germany; Active, not recruiting

Pfizer Investigational Site, Essen 45147, Germany; Active, not recruiting

Pfizer Investigational Site, Berlin 10365, Germany; Active, not recruiting

Pfizer Investigational Site, Ulm 89075, Germany; Active, not recruiting

Pfizer Investigational Site, Ulm 89081, Germany; Active, not recruiting

Pfizer Investigational Site, Frankfurt 60528, Germany; Terminated

Pfizer Investigational Site, Shatin, Hong Kong; Active, not recruiting

Pfizer Investigational Site, Hong Kong, Hong Kong; Active, not recruiting

Pfizer Investigational Site, Kowloon, Hong Kong; Active, not recruiting

Pfizer Investigational Site, Gyor 9023, Hungary; Recruiting

Pfizer Investigational Site, Nyiregyhaza 4400, Hungary; Recruiting

Pfizer Investigational Site, Budapest 1145, Hungary; Recruiting

Pfizer Investigational Site, Lucknow 226 014, India; Recruiting

Pfizer Investigational Site, Chennai 600 006, India; Active, not recruiting

Pfizer Investigational Site, New Delhi 110 002, India; Recruiting

Pfizer Investigational Site, Bologna 40139, Italy; Completed

Pfizer Investigational Site, Foggia 71100, Italy; Recruiting

Pfizer Investigational Site, Pisa 56126, Italy; Active, not recruiting

Pfizer Investigational Site, FIRENZE 50125, Italy; Terminated

Pfizer Investigational Site, Firenze 50125, Italy; Terminated

Pfizer Investigational Site, Seoul 120-752, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 134-701, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Incheon 405-760, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Daejeon 301-721, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Gwangju 501-757, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 137-701, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Riga LV 1002, Latvia; Terminated

Pfizer Investigational Site, Riga LV 1038, Latvia; Terminated

Pfizer Investigational Site, Vilnius 08661, Lithuania; Recruiting

Pfizer Investigational Site, Kaunas 50009, Lithuania; Recruiting

Pfizer Investigational Site, Vilnius 03215, Lithuania; Recruiting

Pfizer Investigational Site, San Luis Potosi 78223, Mexico; Active, not recruiting

Pfizer Investigational Site, Lillehammer 2629, Norway; Active, not recruiting

Pfizer Investigational Site, Trondheim 7006, Norway; Active, not recruiting

Pfizer Investigational Site, Porto 4099-001, Portugal; Active, not recruiting

Pfizer Investigational Site, Coimbra 3000-548, Portugal; Active, not recruiting

Pfizer Investigational Site, Porto 4200-319, Portugal; Terminated

Pfizer Investigational Site, Amadora 2700-276, Portugal; Active, not recruiting

Pfizer Investigational Site, Coimbra 3040-853 Coimbra, Portugal; Active, not recruiting

Pfizer Investigational Site, Bucuresti 050098, Romania; Active, not recruiting

Pfizer Investigational Site, Bucuresti 11461, Romania; Active, not recruiting

Pfizer Investigational Site, Singapore 169608, Singapore; Active, not recruiting

Pfizer Investigational Site, Bratislave, Slovakia; Active, not recruiting

Pfizer Investigational Site, Bratislava 82606, Slovakia; Active, not recruiting

Pfizer Investigational Site, Kosice 04015, Slovakia; Active, not recruiting

Pfizer Investigational Site, Zilina 01207, Slovakia; Completed

Pfizer Investigational Site, Bratislava, Slovakia; Active, not recruiting

Pfizer Investigational Site, GIRONA 17007, Spain; Active, not recruiting

Pfizer Investigational Site, MADRID 28040, Spain; Active, not recruiting

Pfizer Investigational Site, VALENCIA 46009, Spain; Active, not recruiting

Pfizer Investigational Site, VALENCIA 46014, Spain; Completed

Pfizer Investigational Site, Goteborg 413 45, Sweden; Active, not recruiting

Pfizer Investigational Site, Uppsala 75185, Sweden; Active, not recruiting

Pfizer Investigational Site, Linkoping 581 85, Sweden; Active, not recruiting

Pfizer Investigational Site, Taipei, Taiwan; Recruiting

Pfizer Investigational Site, Taipei 112, Taiwan; Recruiting

Pfizer Investigational Site, Tainan, Taiwan; Recruiting

Pfizer Investigational Site, Bangkok 10400, Thailand; Recruiting

Pfizer Investigational Site, Treliske, Truro, Cornwall TR1 3LJ, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Glasgow G11 6NT, United Kingdom; Completed

Pfizer Investigational Site, Liverpool L9 7LJ, United Kingdom; Completed

Pfizer Investigational Site, Zlin, 760 01, Czech Republic; Completed

Pfizer Investigational Site, BADALONA, BARCELONA 08916, Spain; Active, not recruiting

Pfizer Investigational Site, Rajthevee, Bangkok 10400, Thailand; Recruiting

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Recruiting

Pfizer Investigational Site, Mexico, DF 14000, Mexico; Completed

Pfizer Investigational Site, Tallaght, Dublin 24, Ireland; Active, not recruiting

Pfizer Investigational Site, Cluj-Napoca, Jud. Cluj 400012, Romania; Active, not recruiting

Pfizer Investigational Site, Bangalore, Karnataka 560 054, India; Active, not recruiting

Pfizer Investigational Site, Bangalore, Karnataka/India 560 034, India; Active, not recruiting

Pfizer Investigational Site, Muang, Khon Kaen 40002, Thailand; Recruiting

Pfizer Investigational Site, Indore, Madhya Pradesh 452001, India; Recruiting

Pfizer Investigational Site, Xi'an, Shanxi Province 710032, China; Active, not recruiting

Pfizer Investigational Site, Stoke-on-Trent, Staffordshire ST4 7LN, United Kingdom; Completed

Pfizer Investigational Site, Cali, Valle del Cauca, Colombia; Terminated

Pfizer Investigational Site, Den Haag, ZH 2512 VA, Netherlands; Active, not recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2006
Ending date: December 2009
Last updated: October 2, 2009

Page last updated: October 19, 2009

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