Flunarizine for Treatment Resistant Absence Epilepsy
Stopped: The enrollment wasn't as predicted. We didn't have enough numbers to show statistical significance.
Canada9 participantsStarted 2019-09-20
Plain-language summary
This is an open-label, single-centre study to evaluate the clinical efficacy, safety and tolerability of Flunarizine administered as adjunctive treatment in participants diagnosed with treatment resistant absence epilepsy. The study goal is to see how efficient and safe flunarizine is at decreasing the frequency of absence seizures in children with treatment-resistant refractory epilepsy at doses of 5mg and 10mg once daily.
Who can participate
Age range4 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is 4 to 18 years of age
* Participant has treatment resistant absence seizures. Treatment resistant absence seizures are defined as failure to respond to 2 or more appropriate anti-seizure medications (ASMs). The potential participant must have failed to respond to or tolerate appropriate doses of two of the following: ethosuximide (\>/= 20 mg/kg/day), Valproic acid/divalproex sodium (\>/= 15 mg/kg/day) or lamotrigine, (\>/= 5 mg/kg/day).
* Participant must currently be taking a minimum of one ASM
* Normal development (may have specific learning disabilities and/or attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD))
* EEG confirmation of absence seizures and EEG within 2 months of screening visit
* Absence seizures reported at least 10 times per week
* Participants must have no changes in baseline ASMs for 1 month prior to screening period
* Participant or caregiver can maintain a seizure diary
* Participant is able to swallow capsules
* Written informed consent must be provided. Legal guardians of the participants must be able to understand and provide written consent on behalf of the participant, since study participants may be too young to provide informed consent. For participants 7-18 years of age, assent will be required along with written informed consent of the caregiver.
* The participant is willing and able to attend all study visits at British Columbia (BC) Children's Hospital
* Participant has the abil…
What they're measuring
1
Median Percent Change in Weekly absence seizure frequency