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

NCT ID: NCT00280059

Last Updated: 2021-01-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Epilepsy, Partial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

dose 150-600 mg/day given BID

2

Group Type ACTIVE_COMPARATOR

Lamotrigine

Intervention Type DRUG

dose 100-500 mg/day given BID

Interventions

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Pregabalin

dose 150-600 mg/day given BID

Intervention Type DRUG

Lamotrigine

dose 100-500 mg/day given BID

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bruges, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Xi’an, Shanxi, China

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Cheng Du Si Chaun, , China

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Chongqing, , China

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Tianjin, , China

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Bogota, Cundinamarca, Colombia

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Cali, Valle del Cauca Department, Colombia

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Brno, , Czechia

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Hradec Králové, , Czechia

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Ostrava, , Czechia

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Pelhřimov, , Czechia

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Prague, , Czechia

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Rychnov nad Kněžnou, , Czechia

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Zlín, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Kuopio, , Finland

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Tampere, , Finland

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Bordeaux, , France

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Nancy, , France

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Strasbourg, , France

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Berlin, , Germany

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Bonn, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Ulm, , Germany

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Ulm, , Germany

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Hong Kong, , Hong Kong

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Kowloon, , Hong Kong

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Shatin, , Hong Kong

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Budapest, , Hungary

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Győr, , Hungary

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Nyíregyháza, , Hungary

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Bangalore, Karnataka, India

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Indore, Madhya Pradesh, India

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Chennai, Tamil Nadu, India

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Bangalore, , India

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Lucknow, , India

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New Delhi, , India

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Tallaght, Dublin, Ireland

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Bologna, , Italy

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Florence, , Italy

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Foggia, , Italy

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Pisa, , Italy

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Mexico City, Mexico City, Mexico

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San Luis Potosí City, , Mexico

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The Hague, South Holland, Netherlands

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Lillehammer, , Norway

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Trondheim, , Norway

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Amadora, , Portugal

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Coimbra, , Portugal

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Coimbra, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Cluj-Napoca, Jud. Cluj, Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Singapore, , Singapore

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Žilina, , Slovakia

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Daejeon, , South Korea

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Gwangju, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona, Barcelona, Spain

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Girona, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Uppsala, , Sweden

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Rajthevee, Bangkok, Thailand

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Muang, Changwat Khon Kaen, Thailand

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Bangkok, , Thailand

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Stoke-on-Trent, Staffordshire, United Kingdom

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Glasgow, , United Kingdom

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Liverpool, , United Kingdom

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Treliske, Truro, Cornwall, , United Kingdom

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Countries

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

References

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Kwan P, Brodie MJ, Kalviainen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.

Reference Type DERIVED
PMID: 21889410 (View on PubMed)

Related Links

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Other Identifiers

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A0081046

Identifier Type: -

Identifier Source: org_study_id

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