Propranolol Adjuvant Treatment of Focal Refractory Epilepsy (PATFRE)
15 participantsStarted 2024-12-05
Plain-language summary
The aim of this study is to evaluate the clinical efficacy of propranolol as an adjunctive treatment for refractory epilepsy. The significance of this research lies in exploring whether propranolol, as an inhibitor of the CAMP-PKA-MEK/ERK pathway, can provide anticonvulsant effects for a wider range of refractory epilepsy patients. The study holds the potential to offer a novel adjunctive anticonvulsant treatment strategy targeting the CAMP-PKA-MEK/ERK pathway, specifically administered for seizure events, and applicable to various forms of refractory epilepsy.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-60 years of age.
* Meet the 2017 International League Against Epilepsy (ILAE) diagnostic criteria for for focal seizures or focal seizures progressing to bilateral tonic-clonic seizures.
* Diagnosed with refractory epilepsy, having used at least two AEDs without effectiveness for 2 years. No drug interaction between current AEDs and propranolol, and a stable dose for at least 12 weeks prior to enrollment.
* Seizure duration ≥1 minute, with accompanying sensory impairment.
* At least 6 focal seizures within the 12 weeks preceding enrollment.
* EEG or MRI/CT results within the past 2 years, confirming the diagnosis of focal epilepsy.
* The use of vagus nerve stimulation (VNS) and deep brain stimulation (DBS) is permitted, need to implant at least 5 months and stable for at least 12 weeks before enrollment.The parameters should keep unchanged until the end of the study.
* Informed consent signed.
Exclusion Criteria:
* Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations
* Psychogenic non-epileptic seizures within 12 months;
* Treatable causes of epilepsy (such as metabolic disorders, toxicity, infections, space-occupying lesions, or identified genetic abnormalities)
* Patients with only non-motor focal seizures, as classified by the 2017 ILAE.
* Seizure clusters within the 12 months.
* Tonic-clonic status epilepticus within12 months.
* Free of major medical illnesses including:
* Cardiac diseases (history of cardiac valve …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Seizure Frequency Per 28 Days
Timeframe: assessed per 28 days during the treatment.
2
Seizure Responder Rate
Timeframe: short-term treatment period (ending at 3 months); long-term follow-up period (ending at 12 months).