Phenylephrine and Guaifenesin Capsules |
Deconsal II; Entex ER; Entex LA; Guaifed; Guaifed-PD |
Clinical Trial: Treatment of Partial Seizures in Children
This study is currently recruiting patients.
|
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
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
Thomas Enlow, M.D., Principal Investigator
More Information
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
Resources
- Endal Tablets (Drug Digest)
- Entex LA tablets (Drug Digest)

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