NCT06153186

Flunarizine for Treatment Resistant Absence Epilepsy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Childhood Absence Epilepsy
• Juvenile Absence Epilepsy
• Juvenile Myoclonic Epilepsy

Interventions

Type	Name	Description
DRUG	Flunarizine Hydrochloride	Flunarizine tablet

Timeline

• Start date: 2019-09-20
• Primary completion: 2023-05-26
• Completion: 2023-05-26
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: Canada