A Phase 2 interventional study of Flunarizine Hydrochloride in Childhood Absence Epilepsy, Juvenile Absence Epilepsy and Juvenile Myoclonic Epilepsy, sponsored by University of British Columbia. Terminated at 1 site in Canada. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by University of British Columbia · Phase 2, Interventional, and Treatment
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.
Flunarizine (flunarizine hydrochloride) is indicated for prophylaxis of migraine (with and without aura) in patients with frequent and severe attacks, who have not responded to other treatment and/or in whom other therapy has resulted in unacceptable side effects. Flunarizine readily crosses the blood brain barrier and its primary mechanism of action is to preferentially block the entry of calcium under pathophysiological conditions preventing cellular calcium overload by reducing excessive transmembrane calcium influx.
Flunarizine has been used successfully for many years in children with migraines and is a firstline, though off-label, treatment for alternating hemiplegia of childhood. It is not labeled for the control of seizures, but has been safely trialed as an anti-seizure medication with promising results.
The primary objective is to assess the efficacy, safety and tolerability of flunarizine compared to a baseline period on absence seizures in patients with treatment refractory epilepsy taking a minimum of one anti-seizure medication (ASM). The primary outcome measure is median percent change in weekly absence seizure frequency in patients treated with flunarizine compared with the baseline period.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Flunarizine 5 mg capsules will be administered once a day at night. If the 5mg/day dose is tolerated by any given participant, the dose will be escalated to 10mg/day taken as two 5mg capsules at night
Drug: Flunarizine Hydrochloride
Flunarizine tablet
Median Percent Change in Weekly absence seizure frequency
Measuring the median percent change in weekly absence seizure frequency in patients treated with flunarizine compared with the baseline period. This will be measured by evaluating patient seizure diaries at baseline and at the end of the treatment period
Time frame: 12 weeks
Evaluating EEG changes in patients with absence epilepsy
Median percent change in the number of absence seizures captured on EEG, and bursts of spike/wave lasting 2 or more seconds in patients treated with flunarizine compared with the baseline period
Time frame: 12 weeks
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of British Columbia