Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
3–10
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
Clareo Health | A Study for Treatment of Partial Seizures in Children
