Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy - Full Text View

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

Show 102 Study Locations

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