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Clinical Trials/NCT00043901
NCT00043901
Completed
Phase 4

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures

GlaxoSmithKline1 site in 1 country141 target enrollmentDecember 1, 2000
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ConditionsEpilepsy, Tonic-Clonic
Drugslamotrigine

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Epilepsy, Tonic-Clonic
Sponsor
GlaxoSmithKline
Enrollment
141
Locations
1
Primary Endpoint
% change from Baseline in average monthly PGTC seizure frequency
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.

Registry
clinicaltrials.gov
Start Date
December 1, 2000
End Date
March 1, 2005
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

% change from Baseline in average monthly PGTC seizure frequency

Secondary Outcomes

  • Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.

Study Sites (1)

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