A Phase 1b/2a randomized double-blind placebo-controlled parallel-group dose-escalation study to investigate the safety tolerability pharmacokinetics pharmacodynamics and exploratory efficacy of LP352 in subjects with developmental and epileptic encephalopathies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Developmental And Epileptic Encephalopathies
  • Age: Between 18 years - 65 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Male or female adults >18 to <65 years of age at the time of screening with a body mass index <35 kg/m2 and >18 kg/m2.
    2. Diagnosis of developmental and epileptic encephalopathies (DEE) that includes Dravet syndrome, Lennox-Gastaut Syndrome, and other DEEs and demonstrates treatment-resistant countable motor seizures.
    3. Has a reliable caregiver or study partner.
    4. The subject and/or authorized representative are willing and able to provide a written informed consent or assent form before participation in the study.
    5. The subject and/or authorized representative are willing to provide a written consent or assent to allow the investigator and the investigator’s staff to consult with the subject’s medical caregivers and the Medical Monitor during screening and during participation in the study.
    6. All female subjects must have a negative serum pregnancy (human chorionic gonadotropin) test at screening and a negative urine pregnancy test before randomization.
    7. A female subject of childbearing potential who is sexually active with a male partner agrees to use routinely an adequate method of contraception from signing of informed consent, throughout the duration of the study, and for 30 days after the last dose of study drug.
    8. A male subject who is sexually active with a female partner of childbearing potential agrees to use adequate contraception from the signing of informed consent, throughout the duration of the study, and for 90 days after last dose.
    9. The subject, parent, or caregiver is able and willing to comply with completion of the diaries.

You may not be eligible for this study if the following are true:

    1. Has been admitted to a medical facility for treatment of status epilepticus requiring mechanical respiration within 3 months before screening.
    2. Current or prior idiopathic generalized seizures.
    3. Has had a vagus nerve stimulator implanted within 6 months before screening, and/or settings have been changed within 1 month before screening and/or anticipated to change during the study.
    4. Is on a ketogenic diet that has been started within 6 months before the Screening Visit, has been changed within 1 month of the Screening Visit, or is anticipated to change during the study.
    5. Subjects with Dravet syndrome who have used sodium channel blockers, phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, eslicarbazepine, lamotrigine, lacosamide, rufinamide, vigabatrin, tiagabine, pregabalin, and gabapentin within the last month (30 days) before screening.
    6. Has used stiripentol within the last month (30 days) before screening.
    7. Current use of felbamate, unless the subject is on a stable dose of felbamate =12 months before screening with stable liver function and hematology laboratory tests.
    8. Current use of topiramate, unless the subject is on a stable dose of topiramate =12 months before screening with stable weight.
    9. Has used fenfluramine.
    10. Has a clear pattern of perimenstrual exacerbation of seizures.
    11. Considered at risk of suicidal behavior.
    12. Current or recent history of moderate or severe depression, anorexia nervosa, or bulimia.
    13. Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infections.
    14. Has moderate or severe renal impairment.
    15. History of glaucoma.
    16. Past history of recurrent urinary tract infections (UTIs) (=2 documented UTIs in the past 12 months), or current evidence of UTI.
    17. Use of grapefruit juice, grapefruit, Seville oranges or St John’s Wort or products containing these within 30 days before the first administration of study drug, and until the follow-up visit.
    18. Has a history of alcohol, opioid, or other drug use disorder.
    19. Use of any cannabidiol products except Epidiolex.
    20. Has a positive result on the urine drug screen, including tetrahydrocannabinol, but excluding other controlled medications taken as prescribed.
    21. Has pulmonary arterial hypertension, current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, or stroke.
    22. Is pregnant, breast-feeding, or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
    23. Unwilling to abstain from donation of blood during and within 2 weeks after the study.
    24. Travel plans during the treatment and follow-up periods that would preclude clinic visits.
    25. Has been part of a clinical study involving another investigational product in the previous 3 months or subject is currently receiving an investigational product.

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.