Clinical trial NCT00102713: A Study for Treatment of Partial Seizures in Children
Official title: An Open Label Study for Treatment of Partial Seizures in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Seizures
Keywords: Partial Seizures
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.


Eligibility 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 3:

  * EEG at some time in past demonstrating focal abnormalities consistent with partial seizures
  * If the EEG is inconclusive or does not support partial seizures, then an MRI/CT will be done
  * If the MRI/CT fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal Investigator's clinical diagnosis
* Subject weighs at least 15 kg (33 lbs).
* Parent/caregiver is able to keep an accurate seizure diary.

Exclusion Criteria:

* Has had status epilepticus in the past 3 months prior to Screening
* Has a history of any of: 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
* Receiving systemic chemotherapy
* Requires treatment with aspirin
* Subject is pregnant
* 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)

Primary outcomes:
measure: Partial Seizure Rate at Week 4
Secondary outcomes:
measure: Adverse Events
measure: WASI
measure: WPPSI-III
measure: BASC
measure: UKU-Neurologic Assessment
measure: Vital Signs
measure: Clinical Laboratory Assessments
measure: ECG
measure: PK analysis
Other outcomes:
Locations:
city: Northport
country: United States
facility: Neurology Clinic, P.C.
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Tampa
country: United States
facility: Pediatric Epilepsy and Neurology Specialists
state: Florida
city: Atlanta
country: United States
facility: Child Neurology Associates, P.C.
state: Georgia
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: San Antonio
country: United States
facility: Texas Association of Pediatric Neurology, P.A.
state: Texas
city: Norfolk
country: United States
facility: Monarch Medical Research
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Richard V. Colan, M.D., S.C.
state: Wisconsin
Study officials:
affiliation: Abbott
name: Global Medical Information 800-633-9110
role: STUDY_DIRECTOR
References: