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LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
This study has been completed.
Study NCT00144872   Information provided by GlaxoSmithKline
First Received: September 1, 2005   Last Updated: May 15, 2009   History of Changes

September 1, 2005
May 15, 2009
November 2004
 
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)
Same as current
Complete list of historical versions of study NCT00144872 on ClinicalTrials.gov Archive Site
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.
Freq of sz pre/post-trt w LTG, proport of subjs w >=25, 50 and 75% dec in sz freq, proportion of subjs w >=25, 50 and 75% dec in clin signs, proport of subjs sz-free, decrease in sz freq/duration, AEs, behavioral/social functioning, overall status.
 
LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
An Open-Label Evaluation of LAMICTAL (Lamotrigine) Monotherapy for the Treatment of Newly-Diagnosed Typical Absence Seizures in Children and Adolescents

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Epilepsy
Drug: lamotrigine
 
Holmes GL, Frank LM, Sheth RD, Philbrook B, Wooten JD, Vuong A, Kerls S, Hammer AE, Messenheimer J. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children. Epilepsy Res. 2008 Dec;82(2-3):124-32. Epub 2008 Sep 7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
 
 

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.
Both
up to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00144872
Study Director, GSK
LAM100118
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

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