Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy

Last updated: March 1, 2023
Sponsor: ES Therapeutics Australia Pty Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT04714996
ES-481-C201
  • Ages 18-70
  • All Genders

Study Summary

This is a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study with cross-over to Evaluate the Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients with Drug Resistant Epilepsy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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
  2. The subject is a male or female 18 to 70 years of age, inclusive
  3. The subject must have a history of drug resistant epilepsy (as per the ILAEdefinition)
  4. 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
  5. If VNS implanted, the stimulation setting must have been stable for at least fourweeks prior to entering the 28-day screening period
  6. The subject/legal guardian must be able to use the seizure dairy to record seizurethroughout the study
  7. 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
  8. 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.
  9. The subject is willing and able to comply with the study requirements

Exclusion

Exclusion Criteria:

  1. Unwilling or inability to follow the procedures specified by the protocol
  2. Pregnancy or breast feeding
  3. 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)
  4. 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
  5. 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
  6. 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
  7. Concomitant treatment with more than four (4) AEDs
  8. Evidence for a potentially progressive neurologic disorder, such as a brain tumor,multiple sclerosis or dementia
  9. 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
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg, Victoria
    Australia

    Active - Recruiting

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria
    Australia

    Active - Recruiting

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