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Treatment of Partial Seizures in Children - Article


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Ethosuximide Capsules

Zarontin



Clinical Trial: Treatment of Partial Seizures in Children

This study is currently recruiting patients.

Sponsored by: Abbott Laboratories
Information provided by: Abbott Laboratories

Purpose

The purpose of the study is to assess the safety profile of Depakote Sprinkle Capsules in the treatment of partial seizures in children ages 3-10.

Condition Treatment or Intervention Phase
Epilepsies, Partial
 Drug: Divalproex Sodium (Depakote Sprinkle Capsules)
Phase III

MedlinePlus related topics:  Epilepsy

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Official Title: An Open Label Study for Treatment of Partial Seizures in Children

Further Study Details: 
Primary Outcomes: Long term safety

Last follow-up: January 2005

Eligibility

Ages Eligible for Study:  3 Years   -   10 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Subject has diagnosis of partial seizures with/without secondary generalization, supported by:

  • Observed ictal events consistent with partial seizures: With/without secondary generalization; Documented by reliable observers
  • 1 of following 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
  • On stable dose of 1 or 2 antiepileptic drug(s) other than valproate, for at least 1 month
  • Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
  • History of at least 4 partial seizures/month in 2 months prior to screening
  • Parent/caregiver is able to keep an accurate seizure diary

Exclusion Criteria:

  • History of any of following: *Lennox-Gastaut syndrome; *Primary generalized seizures; *Infantile spasms; *Mixed seizure disorders including atypical absence; *Myoclonic or atonic seizures; *Pseudoseizures or Epilepsia Partialis Continuans (EPC)
  • Has had status epilepticus in the past 6 months
  • Has significant history of any of the following that would confound study results: *Cardiac (including clinically important abnormality on ECG); *Renal; *Psychiatric (including psychosurgery); *Oncologic; *Endocrine; *Metabolic; *Pancreatic; *Hepatic disease (including clinical/serological history of hepatitis); *Urea cycle disorder
  • Has: *Expanding CNS neoplasm; *Active CNS infection; *Demyelinating disease; *Degenerative neurological disease; *progressive Encephalopathy; Or *any progressive CNS disease
  • Has platelet count less than or equal to 100,000/mcL
  • Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening
  • Requires anticoagulant drug therapy
  • Not expected to be able to maintain same dose of all pre-study anti-epileptic drugs (AEDs), excluding valproate, throughout study
  • Receiving systemic chemotherapy
  • Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening
  • Has been on ketogenic diet within 30 days prior to screening
  • Considered by investigator to be non-responder to valproate for treatment of epilepsy (e.g., Despite adequate trial with serum concentrations of 60 mcg/mL or greater, subject continues to have inadequate seizure control)

Location and Contact Information


Ohio
      Akron Children’s Hospital, Akron,  Ohio,  44308 1062,  United States; Recruiting
Kimberly J Oldfield  330-543-8050    dgiebner@chmca.org 
Thomas Enlow, M.D.,  Principal Investigator

More Information

Study ID Numbers:  M04-714
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  February 1, 2005
ClinicalTrials.gov Identifier:  NCT00102713
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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