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Non-Interventional Study With LYRICA® In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Information source: Pfizer
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: no intervention (Other)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase

Clinical Details

Official title: Non-Interventional Study With LYRICA In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Study design: Case Control, Cross-Sectional

Primary outcome: The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase,

Secondary outcome:

What average dosage of LYRICA has been achieved in NIS study?

What antiepileptic drugs were used in the past?

To assess the change in 28 day partial seizure frequency from baseline visit to final visit.

To assess the seizure freedom.

What concomitant drugs are used?

Did the treatment with Lyrica have to be stop prematurely?

All adverse events sholud be recorded.

Detailed description: no sampling

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age over 18 years old, patients with epilepsy with partial seizures

- Enrollment to study is fully on physician decision in compliance with current SPC.

Exclusion Criteria:

- Patient who did not meet indication according to SPC Lyrica

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Additional Information

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

Starting date: May 2008
Ending date: March 2009
Last updated: May 22, 2008

Page last updated: August 08, 2008

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