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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00043901
First received: August 14, 2002
Last updated: March 31, 2017
Last verified: March 2017
  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, Tonic-Clonic Drug: lamotrigine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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.

Enrollment: 141
Study Start Date: December 1, 2000
Study Completion Date: March 1, 2005
Primary Completion Date: November 1, 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043901

  Show 87 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LAM40097
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: LAM40097
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: LAM40097
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: LAM40097
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: LAM40097
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: LAM40097
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: LAM40097
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00043901     History of Changes
Other Study ID Numbers: LAM40097
Study First Received: August 14, 2002
Last Updated: March 31, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Additional relevant MeSH terms:
Epilepsy, Generalized
Seizures
Epilepsy
Epilepsy, Tonic-Clonic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on June 28, 2017