Flunarizine for Treatment Resistant Absence Epilepsy

NCT06153186 | Terminated Phase 2 DMC

• 1 other identifier: H19-00185
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Absence Epilepsy; Juvenile Absence Epilepsy; Juvenile Myoclonic Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• Evaluating EEG changes in patients with absence epilepsy

  12 weeks

Study Arms (1)

Flunarizine

EXPERIMENTAL

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

Interventions

Flunarizine Hydrochloride DRUG

Flunarizine tablet

Flunarizine

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 ability to speak and read in English
• Females of child bearing potential who are sexually active must be willing to use contraceptive methods for the duration of the study and 6 months post last dose of study drug.
• Males who are sexually active with females of child bearing potential must be willing to use contraception for the duration of the study and 3 months post last dose of study drug.

You may not qualify if:

• Age \< 4 years, \> 18 years
• Participant has uncontrolled myoclonic or generalized tonic clonic seizures
• Psychogenic non-epileptic seizures
• Known diagnosis of intellectual disability
• Autism spectrum disorder
• Participant is taking carbamazepine, oxcarbazepine, phenytoin, eslicarbazepine, or vigabatrin
• History of poor compliance with medication
• Inability of parent or caregiver to maintain a seizure diary
• History of depression or psychosis
• Participant has previously taken flunarizine and has had an adverse reaction to treatment
• Participants who are pregnant or breastfeeding,
• Presence of extrapyramidal symptoms
• Participants who have clinically significant hepatic impairment as assessed by the investigator
• Participants with known hypersensitivity to flunarizine or any of its ingredients

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Epilepsy, Absence; Myoclonic Epilepsy, Juvenile

Interventions

Flunarizine

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Myoclonic

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: December 1, 2023
• Study Start: September 20, 2019
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

CA (1)