TerminatedPhase 2

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 range

4 Years – 18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Median Percent Change in Weekly absence seizure frequency

Timeframe: 12 weeks

Trial details

NCT IDNCT06153186

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-26

View on ClinicalTrials.gov More Childhood Absence Epilepsy trials