Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-12-31

Brief Summary

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The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pregabalin

Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID).

Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients equal to or greater than 18 years of age with diagnosis of epilepsy with partial seizures having minimum of two partial seizures during a two month period before the baseline visit
* Having a clinical history of epilepsy and AED treatment at least 1 year prior to inclusion

Exclusion Criteria

* AED or Seizures/Epilepsy Related Exclusions:having a treatable cause of seizures
* Having absences seizures
* Having had status epileptics within the year prior to inclusion
* Having a progressive neurological or systematic disorder
* Having known significant renal or hepatic dysfunction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No