Propranolol Adjuvant Treatment of Focal Refractory Epilepsy (PATFRE)
ConditionEpilepsy, Drug Resistant
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Propranolol
DrugOral administration is given solely for the epilepsy seizure event. Dosage: 20mg per dose; The patient's blood pressure and heart rate are monitored after the seizure; if the SBP is above 90 mmHg and the heart rate is above 60 beats per minute, then patients are instructed to take propranolol within 1 hour of a seizure . If the seizure frequency is excessively high, the interval between doses should be no less than 6 hours and the medication should not be administered more than 3 times a day.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Open label single arm, drug propanololExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change From Baseline in Seizure Frequency Per 28 Days
Percent change in 28-day frequency of seizures during the 40 week treatment and follow-up period relative to baseline
Time frame
assessed per 28 days during the treatment.2
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Time frame
short-term treatment period (ending at 3 months); long-term follow-up period (ending at 12 months).Secondary outcomes
1
Seizure Severity
The percent change from baseline in seizure severity evaluated by Liverpool seizure severity scale (LSSS) .
Time frame
Baseline observation period; short-term treatment period (ending at 3 months); long-term follow-up period (ending at 12 months).2
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.
Time frame
Baseline observation period; short-term treatment period (ending at 3 months); long-term follow-up period (ending at 12 months).3
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Time frame
through study completion, 12 months.Locations
Sponsors and contacts
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Xuanwu Hospital, Beijing
Lead sponsor
Peking University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: