A Study for Treatment of Partial Seizures in Children

Partial Seizures Clinical Trial

Official title:

An Open Label Study for Treatment of Partial Seizures in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102713
• Other study ID #: M04-714
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2005
• Last updated: May 17, 2007
• Start date: February 2005

Study information

• Verified date: May 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Partial Seizures
• Seizures

Intervention

Drug:
• Divalproex Sodium (Depakote Sprinkle Capsules)

Locations

Country	Name	City	State
United States	Akron Children’s Hospital	Akron	Ohio
United States	Child Neurology Associates, P.C.	Atlanta	Georgia
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Richard V. Colan, M.D., S.C.	Milwaukee	Wisconsin
United States	Monarch Medical Research	Norfolk	Virginia
United States	Neurology Clinic, P.C.	Northport	Alabama
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Texas Association of Pediatric Neurology, P.A.	San Antonio	Texas
United States	Pediatric Epilepsy and Neurology Specialists	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial Seizure Rate at Week 4
Secondary	Adverse Events
Secondary	WASI
Secondary	WPPSI-III
Secondary	BASC
Secondary	UKU-Neurologic Assessment
Secondary	Vital Signs
Secondary	Clinical Laboratory Assessments
Secondary	ECG
Secondary	PK analysis