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A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children Clinical research trials and A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children. A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children  A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
For Condition: Partial Seizures
Status: Recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/10 Years
Genders: Both
Protocol Entry Criteria: KEY 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) (AED) 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 KEY 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 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 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)
Total Enrollment:
Location and Contact Information:
Texas Association of Pediatric Neurology, PA *Recruiting*
San Antonio, Texas, 78258
United States
Recruiting Rose Espitia 210-949-0505
PCTI / Children's Hospital *Recruiting*
Columbus, Ohio, 43205
United States
Recruiting Sarah Borror 614-722-2650
Primary Physician's Research *Recruiting*
Pittsburgh, Pennsylvania,
United States
Recruiting Denise Musolino 412-257-4461
Rainbow Babies Children's Hospital *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Lucy Andrews-Mann 216-844-3681
Pediatric Epilepsy & Neurology Specialist *Recruiting*
Tampa, Florida, 33607
United States
Recruiting William Smit 813-873-7367
University Hospital of Cleveland *Recruiting*
Cleveland, Ohio,
United States
Recruiting Eloise Lemon 216-844-3681
Additional Information:
Study ID Numbers: M02-552;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067431
Other Partial Seizures Studies:
1. A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
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Other Partial Seizures Clinical Trials
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A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
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