Enrolling Now - 1
A Double0Blind, Placebo-Controlled, Dose escalation study with an Open-Label phase to examine the Safety, Tolerability, PK and PD of TAK935 as an adjunct Therapy in subjects with developmental or Epileptic Encephalopathies.
PI: Marcelo Lancman, MD
Sponsor: Takeda Pharmaceuticals
Mechanism of action : TAK 935 is a potent and selective cholesterol 24 S-hydroxylase(CH2 4H) inhibitor.
Study Duration: 4 months
Number of visits: 9
Key Eligibility Criteria:
* Age 18-65 male or female
* Having a diagnosis of developmental or Epileptic Encephalopathies
* Has a legally acceptable representative to sign consent form
* Countable 2 or more motor seizures per month during the past 3 months
* 1- 4 AEDs at a stable dose for 4 weeks prior to screening visit
Key Exclusion Criteria:
* The subject has been admitted to a hospital for treatment of status epilepticus within 6 months before Visit 1
* Intermittent use of Benzodiazepines as rescue more than 3 times a week
* History of Drug abuse
* History of Suicidal behavior or any suicidal ideation at the screening visit