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

Completed · Phase 4

Conditions studied: Epilepsy, Tonic-Clonic

In brief

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.

Key facts

Study ID

NCT00043901

Run by

GlaxoSmithKline

People needed

141

Starts

2000-12-01

Expected to finish

2005-03-01

Last updated by the study team

2017-04-04

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Northport, Alabama, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Newark, Delaware, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Gainsville, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Panama City, Florida, United States
• GSK Investigational Site — Tallahassee, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — Boise, Idaho, United States
• GSK Investigational Site — Idaho Falls, Idaho, United States
• GSK Investigational Site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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