A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects Wi… (NCT02899611) | Clinical Trial Compass
CompletedPhase 1/2
A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures
Australia6 participantsStarted 2016-08
Plain-language summary
Patients with medically refractory epilepsy will be treated by intracerebroventricular (ICV) delivery of valproate using an implantable drug pump system. The dose of valproate will be escalated weekly during a blinded-evaluation period through Day 64 to determine the maximum tolerated dose (MTD). After Day 64, patients can continue for 52 weeks in the open-label evaluation period (non-blinded). .
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subject is 18 to 65 years old.
✓. Subject does not have coagulopathy, ventricular anatomic distortion or abnormally low brain weight or significant volume loss etc. and is approved to have surgery.
✓. Subject had onset of epilepsy after age 5, had normal brain development up to age 5, and has full scale IQ \> 70 by testing or functional assessment.
✓. Subject has brain volume which is not noted to be abnormally small due to atrophy by either the radiologist reading on MRI scan or the treating clinicians (the neurosurgeon) review of the MRI scan.
✓. Subject has had confirmed epilepsy for a minimum of 1 year, with diagnosis of focal seizures with temporal lobe onset, with or without secondarily generalized seizures, as defined by the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981).
✓. In the opinion of the investigator, subject has disabling seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
✓. Subject has had a CT or MRI of the brain to rule out progressive structural lesions.
✓. Subject has had an EEG or video EEG or invasive monitoring within the past 3 yrs consistent with partial seizures (a normal interictal EEG is consistent with partial seizures)
Exclusion criteria
✕. Subject has any significant neurologic disease other than epilepsy.
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: 2 months
2
Safety: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
. Subject has history, within 12 months prior to Screening, of repetitive seizures that cannot be counted.
✕. Subject has pseudoseizures or seizures secondary to illicit drug or alcohol use, neoplasia, active CNS infection, demyelinating disease, degenerative neurological disease, progressive central nervous system disease or metabolic illness.
✕. Subject has been diagnosed with partial motor, primarily generalized seizures or has been diagnosed with psychogenic or nonepileptic seizures in the preceding year.
✕. Subject has had status epilepticus refractory to benzodiazepines and phenytoin within one year prior to Screening
✕. Subject is currently taking neuroleptic medication for behavior control.
✕. Subject is taking scheduled doses of benzodiazepines or has required, in the 3 months prior to Screening, benzodiazepine use more than 4 times per month for seizure control. One use is defined as taking up to 3 doses in a 24 hour period.
✕. Subject is currently implanted with an activated DBS, or RNS device used for treatment of a neurologic or psychiatric condition.