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Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
This study has been completed.
First Received: August 14, 2002   Last Updated: October 29, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00043901
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: lamotrigine
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • % change from Baseline in average monthly PGTC seizure frequency

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

Estimated Enrollment: 104
Study Start Date: December 2000
  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Weigh at least 13kg.
  • Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
  • Currently being treated with an antiepileptic drug(s) (AED).
  • Benzodiazepines are allowed with some frequency restrictions.
  • Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
  • History of primary generalized tonic-clonic seizures with no focal onset.
  • Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study.
  • Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study.
  • Females must agree to acceptable form of birth control.

EXCLUSION CRITERIA:

  • A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
  • Have Lennox-Gastaut syndrome.
  • Currently using or has previously used the drug being studied.
  • Is abusing alcohol and/or other substance(s).
  • Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study.
  • Is receiving chronic (long-term) treatment with any medication that could influence seizure control.
  • Follows the ketogenic diet.
  • Is planning surgery to control seizures during the study.
  • Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality.
  • Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043901

  Show 89 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: LAM40097
Study First Received: August 14, 2002
Last Updated: October 29, 2009
ClinicalTrials.gov Identifier: NCT00043901     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Lamotrigine
epilepsy
primary generalized tonic-clonic
PGTC
seizures

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Seizures
Nervous System Diseases
Central Nervous System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions
Membrane Transport Modulators
Signs and Symptoms
Epilepsy
Therapeutic Uses
Lamotrigine
Neurologic Manifestations
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 22, 2009