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Completed

NCT Number: NCT00113165

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy, Partial Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of epilepsy with partial seizures for more than 24 weeks.
  • Must experience at least 8 partial seizures during an 8-week Baseline Phase.
  • Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
  • Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

Exclusion criteria

  • Previous treatment with lamotrigine.
  • Exhibits any primary generalized seizures.
  • Receiving treatment with felbamate or currently following the ketogenic diet.
  • Pregnant, breastfeeding, or planning to become pregnant.

Treatment and study plan

LAMICTAL extended-release

Drug

Primary outcomes

  1. The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.

    Time frame: 24 Weeks

Secondary outcomes

  1. Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics

    Time frame: 24 Weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 7, 2005
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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