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Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00043901
First received: August 14, 2002
Last updated: January 26, 2012
Last verified: January 2012
History of Changes

August 14, 2002
January 26, 2012
December 2000
November 2003   (final data collection date for primary outcome measure)
% change from Baseline in average monthly PGTC seizure frequency
Not Provided
Complete list of historical versions of study NCT00043901 on ClinicalTrials.gov Archive Site
Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.
Not Provided
Not Provided
Not Provided
 
Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Epilepsy, Tonic-Clonic
Drug: lamotrigine
Other Name: lamotrigine
Not Provided
Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer JA. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology. 2005 Dec 13;65(11):1737-43.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
November 2003
November 2003   (final data collection date for primary outcome measure)

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.
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Chile,   Peru
 
NCT00043901
LAM40097
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP