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Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
This study is currently recruiting participants.
Verified by Pfizer, November 2009
First Received: January 18, 2006   Last Updated: November 23, 2009   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00280059
  Purpose

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.


Condition Intervention Phase
Epilepsy, Partial
 Drug: Pregabalin
Drug: Lamotrigine
 Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Lamotrigine Pregabalin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of patients seizure-free for 6 months during the efficacy assessment phase (excluding dose escalation phase). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep Scale [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • Seizure freedom by month and by avg. daily dose [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Anxiety and Depression Scale [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • Time to 6-month seizure-freedom [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]
  • Time to 1st seizure [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]
  • Time to exit due to adverse event, lack of efficacy, or any reason [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 626
Study Start Date: August 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Pregabalin
dose 150-600 mg/day given BID
2: Active Comparator Drug: Lamotrigine
dose 100-500 mg/day given BID

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280059

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
Belgium
Pfizer Investigational Site Active, not recruiting
Leuven, Belgium, 3000
Pfizer Investigational Site Completed
Brugge, Belgium, 8000
Pfizer Investigational Site Active, not recruiting
Bruxelles, Belgium, 1070
Bulgaria
Pfizer Investigational Site Recruiting
Plovdiv, Bulgaria, 4000
Pfizer Investigational Site Recruiting
Sofia, Bulgaria, 1524
Pfizer Investigational Site Recruiting
Sofia, Bulgaria, 1113
Pfizer Investigational Site Recruiting
Varna, Bulgaria, 9010
Pfizer Investigational Site Recruiting
Sofia, Bulgaria, 1309
China
Pfizer Investigational Site Active, not recruiting
Cheng Du Si Chaun, China, 610041
Pfizer Investigational Site Active, not recruiting
Tian Jin, China, 300052
Pfizer Investigational Site Active, not recruiting
Chongqing, China, 400016
China, Shanxi Province
Pfizer Investigational Site Active, not recruiting
Xi'an, Shanxi Province, China, 710032
Colombia, Cundinamarca
Pfizer Investigational Site Recruiting
Bogota, Cundinamarca, Colombia, 0
Colombia, Valle del Cauca
Pfizer Investigational Site Terminated
Cali, Valle del Cauca, Colombia
Czech Republic
Pfizer Investigational Site Active, not recruiting
Ostrava, Czech Republic, 708 58
Pfizer Investigational Site Active, not recruiting
Praha 4, Czech Republic, 140 59
Pfizer Investigational Site Active, not recruiting
Brno 2, Czech Republic, 602 00
Pfizer Investigational Site Active, not recruiting
Pelhrimov, Czech Republic, 393 01
Pfizer Investigational Site Active, not recruiting
Hradec Kralove, Czech Republic, 500 05
Pfizer Investigational Site Active, not recruiting
Rychnov Nad Kneznou, Czech Republic, 516 01
Czech Republic, 760 01
Pfizer Investigational Site Completed
Zlin, 760 01, Czech Republic
Estonia
Pfizer Investigational Site Recruiting
Tartu, Estonia, 51014
Pfizer Investigational Site Completed
Tallinn, Estonia, 10138
Finland
Pfizer Investigational Site Active, not recruiting
Kuopio, Finland, 70210
Pfizer Investigational Site Active, not recruiting
Tampere, Finland, 33520
France
Pfizer Investigational Site Active, not recruiting
Nancy Cedex, France, 54035
Pfizer Investigational Site Active, not recruiting
Strasbourg Cedex, France, 67091
Pfizer Investigational Site Active, not recruiting
Bordeaux Cedex, France, 33076
Germany
Pfizer Investigational Site Active, not recruiting
Bonn, Germany, 53105
Pfizer Investigational Site Active, not recruiting
Ulm, Germany, 89075
Pfizer Investigational Site Active, not recruiting
Berlin, Germany, 10365
Pfizer Investigational Site Active, not recruiting
Essen, Germany, 45147
Pfizer Investigational Site Active, not recruiting
Ulm, Germany, 89081
Pfizer Investigational Site Terminated
Frankfurt, Germany, 60528
Hong Kong
Pfizer Investigational Site Active, not recruiting
Shatin, Hong Kong
Pfizer Investigational Site Active, not recruiting
Hong Kong, Hong Kong
Pfizer Investigational Site Active, not recruiting
Kowloon, Hong Kong
Hungary
Pfizer Investigational Site Recruiting
Gyor, Hungary, 9023
Pfizer Investigational Site Recruiting
Nyiregyhaza, Hungary, 4400
Pfizer Investigational Site Recruiting
Budapest, Hungary, 1145
India
Pfizer Investigational Site Recruiting
Lucknow, India, 226 014
Pfizer Investigational Site Active, not recruiting
Chennai, India, 600 006
Pfizer Investigational Site Recruiting
New Delhi, India, 110 002
India, Karnataka
Pfizer Investigational Site Active, not recruiting
Bangalore, Karnataka, India, 560 054
India, Karnataka/India
Pfizer Investigational Site Active, not recruiting
Bangalore, Karnataka/India, India, 560 034
India, Madhya Pradesh
Pfizer Investigational Site Recruiting
Indore, Madhya Pradesh, India, 452001
Ireland, Dublin
Pfizer Investigational Site Active, not recruiting
Tallaght, Dublin, Ireland, 24
Italy
Pfizer Investigational Site Completed
Bologna, Italy, 40139
Pfizer Investigational Site Recruiting
Foggia, Italy, 71100
Pfizer Investigational Site Active, not recruiting
Pisa, Italy, 56126
Pfizer Investigational Site Terminated
Firenze, Italy, 50125
Korea, Republic of
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site Active, not recruiting
Daejeon, Korea, Republic of, 301-721
Pfizer Investigational Site Active, not recruiting
Incheon, Korea, Republic of, 405-760
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 134-701
Pfizer Investigational Site Active, not recruiting
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 137-701
Latvia
Pfizer Investigational Site Terminated
Riga, Latvia, LV 1002
Pfizer Investigational Site Terminated
Riga, Latvia, LV 1038
Lithuania
Pfizer Investigational Site Recruiting
Vilnius, Lithuania, 08661
Pfizer Investigational Site Recruiting
Kaunas, Lithuania, 50009
Pfizer Investigational Site Recruiting
Vilnius, Lithuania, 03215
Mexico
Pfizer Investigational Site Active, not recruiting
San Luis Potosi, Mexico, 78223
Mexico, DF
Pfizer Investigational Site Completed
Mexico, DF, Mexico, 14000
Netherlands, ZH
Pfizer Investigational Site Active, not recruiting
Den Haag, ZH, Netherlands, 2512 VA
Norway
Pfizer Investigational Site Active, not recruiting
Lillehammer, Norway, 2629
Pfizer Investigational Site Active, not recruiting
Trondheim, Norway, 7006
Portugal
Pfizer Investigational Site Active, not recruiting
Porto, Portugal, 4099-001
Pfizer Investigational Site Active, not recruiting
Coimbra, Portugal, 3000-548
Pfizer Investigational Site Terminated
Porto, Portugal, 4200-319
Pfizer Investigational Site Active, not recruiting
Amadora, Portugal, 2700-276
Pfizer Investigational Site Active, not recruiting
Coimbra, Portugal, 3040-853 Coimbra
Romania
Pfizer Investigational Site Active, not recruiting
Bucuresti, Romania, 050098
Pfizer Investigational Site Active, not recruiting
Bucuresti, Romania, 11461
Romania, Jud. Cluj
Pfizer Investigational Site Active, not recruiting
Cluj-Napoca, Jud. Cluj, Romania, 400012
Singapore
Pfizer Investigational Site Active, not recruiting
Singapore, Singapore, 169608
Slovakia
Pfizer Investigational Site Active, not recruiting
Bratislave, Slovakia
Pfizer Investigational Site Active, not recruiting
Bratislava, Slovakia, 82606
Pfizer Investigational Site Active, not recruiting
Bratislava, Slovakia
Pfizer Investigational Site Completed
Zilina, Slovakia, 01207
Pfizer Investigational Site Active, not recruiting
Kosice, Slovakia, 04015
Spain
Pfizer Investigational Site Active, not recruiting
Girona, Spain, 17007
Pfizer Investigational Site Active, not recruiting
Madrid, Spain, 28040
Pfizer Investigational Site Active, not recruiting
Valencia, Spain, 46009
Pfizer Investigational Site Completed
Valencia, Spain, 46014
Spain, BARCELONA
Pfizer Investigational Site Active, not recruiting
Badalona, BARCELONA, Spain, 08916
Sweden
Pfizer Investigational Site Active, not recruiting
Goteborg, Sweden, 413 45
Pfizer Investigational Site Active, not recruiting
Uppsala, Sweden, 75185
Pfizer Investigational Site Active, not recruiting
Linkoping, Sweden, 581 85
Taiwan
Pfizer Investigational Site Recruiting
Taipei, Taiwan
Pfizer Investigational Site Recruiting
Taipei, Taiwan, 112
Pfizer Investigational Site Recruiting
Tainan, Taiwan
Thailand
Pfizer Investigational Site Recruiting
Bangkok, Thailand, 10400
Thailand, Bangkok
Pfizer Investigational Site Recruiting
Rajthevee, Bangkok, Thailand, 10400
Thailand, Khon Kaen
Pfizer Investigational Site Recruiting
Muang, Khon Kaen, Thailand, 40002
United Kingdom
Pfizer Investigational Site Active, not recruiting
Treliske, Truro, Cornwall, United Kingdom, TR1 3LJ
Pfizer Investigational Site Completed
Glasgow, United Kingdom, G11 6NT
Pfizer Investigational Site Completed
Liverpool, United Kingdom, L9 7LJ
United Kingdom, Staffordshire
Pfizer Investigational Site Completed
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 7LN
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers: A0081046
Study First Received: January 18, 2006
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00280059     History of Changes
Health Authority: United Kingdom: European Medicines Agency

Keywords provided by Pfizer:
Epilepsy
partial seizures
pregabalin monotherapy
lamotrigine comparator
double-blind and randomized trial

Additional relevant MeSH terms:
Epilepsies, Partial
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Pregabalin
Calcium Channel Blockers
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions
 Membrane Transport Modulators
Sensory System Agents
Epilepsy
Therapeutic Uses
Lamotrigine
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009



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