Last updated: March 1, 2023
Sponsor: ES Therapeutics Australia Pty Ltd
Overall Status: Active - Recruiting
Phase
2
Condition
Epilepsy
Treatment
N/AClinical Study ID
NCT04714996
ES-481-C201
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The subject/legal guardian must be able to understand and sign the Human ResearchEthics Committee-approved written Informed Consent Form (ICF) and privacy language asper national regulations (e.g., HREC and TGA requirement in Australia) prior to anystudy-related procedures being performed
- The subject is a male or female 18 to 70 years of age, inclusive
- The subject must have a history of drug resistant epilepsy (as per the ILAEdefinition)
- The subject must be taking 1 to 4 antiepileptic drugs (AED) and must be on a stabledose of the AEDs for at least four (4) weeks prior to entering the 28-day screeningperiod
- If VNS implanted, the stimulation setting must have been stable for at least fourweeks prior to entering the 28-day screening period
- The subject/legal guardian must be able to use the seizure dairy to record seizurethroughout the study
- The subject must experience at least four (4) countable seizures within a 28-dayperiod. For continued enrollment into Treatment Period 1, each subject will be confirmed tohave experienced at least four (4) countable seizures in the 28-day screening period
- The subject must have interictal epileptiform discharges and/or seizure with anaverage frequency of at least one (1) per hour on EEG recording. For continued enrollment into Treatment Period 1, this will be confirmed by a 24-hourEEG performed during the 28-day screening period.
- The subject is willing and able to comply with the study requirements
Exclusion
Exclusion Criteria:
- Unwilling or inability to follow the procedures specified by the protocol
- Pregnancy or breast feeding
- Women of child-bearing potential and men who are unable or unwilling to take adequatecontraceptive precautions, including one of the following: Hormonal contraception (birth control pills, injected hormones or vaginal ring)Intrauterine device Barrier methods (condom or diaphragm) combined withspermicideSurgical sterilization (hysterectomy, tubal ligation, or vasectomy)
- Current treatment for another significant medical disorder, such as diabetes, or heartdisease or an untreated disorder, that is discovered during the 28-day screeningperiod and might interfere with the study in the opinion of the Principal Investigator
- An abnormality on clinical laboratory tests, physical examination, EEG or ECG thatmight increase the risks associated with trial participation or investigationalproduct administration, such as hepatic enzyme elevation greater than twice normaland/or a GFR < 60 mL/min/1.73 m2
- History (within the month) of illicit drug use or alcohol dependence, and a commitmentby the subject to not take the illicit drugs during the study
- Concomitant treatment with more than four (4) AEDs
- Evidence for a potentially progressive neurologic disorder, such as a brain tumor,multiple sclerosis or dementia
- Planned epilepsy surgery within six months of enrollment
Study Design
Total Participants: 24
Study Start date:
October 30, 2020
Estimated Completion Date:
December 31, 2023
Connect with a study center
Royal Brisbane and Women's Hospital
Herston, Queensland
AustraliaActive - Recruiting
Austin Hospital
Heidelberg, Victoria
AustraliaActive - Recruiting
Alfred Health
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Royal Melbourne Hospital
Parkville, Victoria
AustraliaActive - Recruiting
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