Flunarizine for Treatment Resistant Absence Epilepsy

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06153186
Study type	Interventional
Source	University of British Columbia
Contact
Status	Terminated
Phase	Phase 2
Start date	September 20, 2019
Completion date	May 26, 2023

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT03355300` - Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures	Phase 2
Terminated	`NCT03336242` - Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures	Phase 2
Completed	`NCT00361010` - A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy	N/A
Completed	`NCT00041951` - Search for Genes Influencing Childhood Absence Epilepsy (CAE) Study	N/A
Not yet recruiting	`NCT06315322` - A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy	Phase 3
Not yet recruiting	`NCT06310772` - Assessing Comorbidities in Epilepsy Using Eye Movement Recordings