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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brugge, , 8000 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsy
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.

NCT00280059
Pfizer
Completed
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

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Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Epilepsy, Partial
  • Drug: Pregabalin
    dose 150-600 mg/day given BID
  • Drug: Lamotrigine
    dose 100-500 mg/day given BID
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Active Comparator: 2
    Intervention: Drug: Lamotrigine
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.
 
Completed
660
April 2010
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00280059
A0081046
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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