Trial record 8 of 13 for:    "Epilepsy Juvenile Absence"

LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00144872
First received: September 1, 2005
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.


Condition Intervention Phase
Epilepsy
Seizure, Absence
Drug: lamotrigine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Evaluation of LAMICTAL (Lamotrigine) Monotherapy for the Treatment of Newly-diagnosed Typical Absence Seizures in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG)

Secondary Outcome Measures:
  • Freq of seizures pre/post-treatment with lamotrigine, proportion of subjects with >=25, 50 and 75% decrease in seizure frequency, proportion of subjects with >=25, 50 and 75% decrease in clinical signs.

Estimated Enrollment: 50
Study Start Date: November 2004
Intervention Details:
    Drug: lamotrigine
    Other Name: lamotrigine
  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs).
  • Diagnosis demonstrated on one of two 5-minute hyperventilation tests.
  • Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures.
  • Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form.
  • Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated.

Exclusion criteria:

  • Seizures are the result of a currently active, known, and identifiable intracerebral lesion.
  • Has partial or generalized tonic-clonic seizures.
  • Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase.
  • Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization.
  • Has any clinically significant chronic cardiac, renal, or hepatic medical condition.
  • Has a condition that affects the absorption, distribution, metabolism, or excretion of drugs.
  • Is currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder.
  • Has taken any investigational drug within 12 weeks prior to the Screen Phase.
  • Is sexually active.
  • Is either pregnant (i.e., confirmed by pregnancy test at Screen) or breastfeeding.
  • Has a clinically significant chronic medical disorder which the investigator and/or GSK medical monitor determine warrants exclusion.
  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: NCT00144872

Locations
United States, California
GSK Investigational Site
San Jose, California, United States, 95128
United States, Florida
GSK Investigational Site
Loxahatchee, Florida, United States, 33470
GSK Investigational Site
Melbourne, Florida, United States, 32901
GSK Investigational Site
Panama City, Florida, United States, 32405
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Tampa, Florida, United States, 33607-6350
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Missouri
GSK Investigational Site
Springfield, Missouri, United States, 65804
United States, New Jersey
GSK Investigational Site
Newark, New Jersey, United States, 07103
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14222
GSK Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7600
GSK Investigational Site
Greenville, North Carolina, United States, 27834
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Tennessee
GSK Investigational Site
Germantown, Tennessee, United States, 38138
United States, Texas
GSK Investigational Site
Fort Worth, Texas, United States, 76104
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98105
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00144872     History of Changes
Other Study ID Numbers: LAM100118
Study First Received: September 1, 2005
Last Updated: March 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Absence Seizures
EEG
LTG
Typical Absence Epilepsy
Epilepsy
LAMICTAL

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

ClinicalTrials.gov processed this record on July 23, 2014