Clinical Trials

Enrolling Now - 2

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

 

Back