Childhood Absence EpilepsyPhase 2NCT06153186
Flunarizine for Treatment Resistant Absence Epilepsy
A Phase 2 study testing Flunarizine Hydrochloride in people with Childhood Absence Epilepsy and Juvenile Absence Epilepsy, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Childhood Absence Epilepsy, Juvenile Absence Epilepsy, Juvenile Myoclonic Epilepsy
- What is being tested?
- Flunarizine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2019to 26 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Flunarizine Hydrochloride
- Medical subject headings
- Epilepsy, Absence, Myoclonic Epilepsy, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flunarizine HydrochlorideDrug
Flunarizine tablet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Flunarizine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start20 Sep 2019
- Primary completion26 May 2023
- Study completion26 May 2023
Why it stopped: The enrollment wasn't as predicted. We didn't have enough numbers to show statistical significance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Absence EpilepsyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Connolly, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153186
- Sponsor's protocol ID
- H19-00185
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flunarizine for Treatment Resistant Absence Epilepsy
- ClinicalTrials.gov ID
- NCT06153186
- Acronym / sponsor ID
- H19-00185
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment wasn't as predicted. We didn't have enough numbers to show statistical significance.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flunarizine | Experimental | Drug: Flunarizine HydrochlorideFlunarizine 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 |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flunarizine HydrochlorideFlunarizine tablet | Drug | Flunarizine |
Primary outcome
Median Percent Change in Weekly absence seizure frequency
Time frame: 12 weeks
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
1 secondary outcome
Evaluating EEG changes in patients with absence epilepsy
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: The enrollment wasn't as predicted. We didn't have enough numbers to show statistical significance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flunarizine Hydrochloride in people with Childhood Absence Epilepsy and Juvenile Absence Epilepsy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The enrollment wasn't as predicted. We didn't have enough numbers to show statistical significance.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Percent Change in Weekly absence seizure frequency (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.