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

NCT00280059 | Completed Phase 3 Results

• 1 other identifier: A0081046
• Study Type: interventional
• Target: 660
• Locations: 28 countries
• Sites: 100

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.

Conditions

Epilepsy, Partial

Keywords

Epilepsy; partial seizures; pregabalin monotherapy; lamotrigine comparator; double-blind and randomized trial

Outcome Measures

Primary Outcomes (1)

• Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase

  Responders = participants who achieved any 6 consecutive months (\>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.

  Week 5 up to Week 56

Secondary Outcomes (17)

• Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures

  Week 4 up to Week 56

• Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)

  Week 0 to Week 56

• Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)

  Week 0 to Week 56

• Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase

  Week 4 up to Week 56

• Exit Due to Any Reason After 4-week Dose Escalation Phase

  Week 4 up to Week 56

Study Arms (2)

1

EXPERIMENTAL

Drug: Pregabalin

2

ACTIVE COMPARATOR

Drug: Lamotrigine

Interventions

Pregabalin DRUG

dose 150-600 mg/day given BID

1

Lamotrigine DRUG

dose 100-500 mg/day given BID

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (102)

Pfizer Investigational Site

Bruges, 8000, Belgium

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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Plovdiv, 4000, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1524, Bulgaria

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Varna, 9010, Bulgaria

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Xi’an, Shanxi, 710032, China

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Cheng Du Si Chaun, 610041, China

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Chongqing, 400016, China

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Tianjin, 300052, China

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Bogota, Cundinamarca, 0, Colombia

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Cali, Valle del Cauca Department, Colombia

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Brno, 602 00, Czechia

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Hradec Králové, 500 05, Czechia

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Ostrava, 708 58, Czechia

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Pelhřimov, 393 01, Czechia

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Prague, 140 59, Czechia

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Rychnov nad Kněžnou, 516 01, Czechia

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Zlín, 760 01, Czechia

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Tallinn, 10138, Estonia

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Tartu, 51014, Estonia

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Kuopio, 70210, Finland

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Tampere, 33520, Finland

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Bordeaux, 33076, France

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Nancy, 54035, France

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Strasbourg, 67091, France

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Berlin, 10365, Germany

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Bonn, 53105, Germany

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Essen, 45147, Germany

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Frankfurt, 60528, Germany

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Ulm, 89075, Germany

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Ulm, 89081, 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, 1145, Hungary

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Győr, 9023, Hungary

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Nyíregyháza, 4400, Hungary

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Bangalore, Karnataka, 560 054, India

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Indore, Madhya Pradesh, 452001, India

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Chennai, Tamil Nadu, 600 006, India

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Bangalore, 560 034, India

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Lucknow, 226 014, India

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New Delhi, 110 002, India

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Tallaght, Dublin, 24, Ireland

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Bologna, 40139, Italy

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Florence, 50125, Italy

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Foggia, 71100, Italy

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Pisa, 56126, Italy

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Riga, LV 1002, Latvia

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Riga, LV 1038, Latvia

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Kaunas, 50009, Lithuania

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Vilnius, 03215, Lithuania

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Vilnius, 08661, Lithuania

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Mexico City, Mexico City, 14000, Mexico

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San Luis Potosí City, 78223, Mexico

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The Hague, South Holland, 2512 VA, Netherlands

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Lillehammer, 2629, Norway

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Trondheim, 7006, Norway

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Amadora, 2700-276, Portugal

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Coimbra, 3000-548, Portugal

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Coimbra, 3040-853 Coimbra, Portugal

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Porto, 4099-001, Portugal

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Porto, 4200-319, Portugal

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Cluj-Napoca, Jud. Cluj, 400012, Romania

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Bucharest, 050098, Romania

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Bucharest, 11461, Romania

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Singapore, 169608, Singapore

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Bratislava, 813 69, Slovakia

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Bratislava, 82606, Slovakia

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Bratislava, 833 05, Slovakia

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Košice, 04015, Slovakia

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Žilina, 012 07, Slovakia

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Daejeon, 301-721, South Korea

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Gwangju, 501-757, South Korea

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Incheon, 405-760, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 134-701, South Korea

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Seoul, 135-710, South Korea

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Seoul, 137-701, South Korea

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Seoul, 138-736, South Korea

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Badalona, Barcelona, 08916, Spain

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Girona, 17007, Spain

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Madrid, 28040, Spain

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Valencia, 46009, Spain

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Valencia, 46014, Spain

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Gothenburg, 413 45, Sweden

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Linköping, 581 85, Sweden

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Uppsala, 75185, Sweden

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Tainan, Taiwan

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Taipei, 112, Taiwan

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Taipei, Taiwan

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Rajthevee, Bangkok, 10400, Thailand

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Muang, Changwat Khon Kaen, 40002, Thailand

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Bangkok, 10400, Thailand

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Stoke-on-Trent, Staffordshire, ST4 7LN, United Kingdom

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Glasgow, G11 6NT, United Kingdom

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Liverpool, L9 7LJ, United Kingdom

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Treliske, Truro, Cornwall, TR1 3LJ, United Kingdom

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Related Publications (1)

• 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.

  PMID: 21889410 DERIVED

Related Links

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

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Seizures

Interventions

Pregabalin; Lamotrigine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Cox proportional hazards model for time to event (TTE) analyses; three summary statistics were not generated as median TTE will not exist if survival function (Kaplan-Meier product limit estimates) does not fall below 0.5 (post-hoc analysis).

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 20, 2006
• Study Start: August 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: January 28, 2021
• Results First Posted: October 24, 2011

Record last verified: 2015-03

Locations

IT (4); BE (3); BU (5); TW (3); CZ (7); CN (4); SE (3); ES (5); FI (2); IE (1); RO (3); NO (2); KR (9); SL (5); HU (3); DE (6); ME (2); IN (6); NL (1); PT (5); LI (3); CO (2); FR (3); SG (1); HK (3); LA (2); TH (3); GB (4)