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

NCT00280059

Last updated date
Study Location
Pfizer Investigational Site
Brugge, , 8000, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epilepsy, Partial
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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


- Primary generalized seizures.

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Epilepsy, PartialStudy Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
NCT00280059
  1. Brugge,
  2. Bruxelles,
  3. Leuven,
  4. Plovdiv,
  5. Sofia,
  6. Sofia,
  7. Sofia,
  8. Varna,
  9. Xi'an, Shanxi
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  11. Chongqing,
  12. Tian Jin,
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  14. Cali, Valle del Cauca
  15. Brno 2,
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  21. Zlin,
  22. Tallinn,
  23. Tartu,
  24. Kuopio,
  25. Tampere,
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  27. Nancy Cedex,
  28. Strasbourg Cedex,
  29. Berlin,
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  32. Frankfurt,
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  35. Hong Kong,
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  100. Glasgow,
  101. Liverpool,
  102. Treliske, Truro, Cornwall,
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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  ICMJE
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Active Comparator: 2
    Intervention: Drug: Lamotrigine
Publications * Kwan P, Brodie MJ, Kälviäinen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2010)
660
Original Enrollment  ICMJE
 (submitted: January 18, 2006)
786
Actual Study Completion Date  ICMJE April 2010
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00280059
Other Study ID Numbers  ICMJE A0081046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

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