Drug resistant epilepsy Neurosteroids, Progesterone, Drug resistant epilepsy
Conditions
Interventions
Oral micronized progesterone 200 mg in soft gelatin capsules. Adminitered 2 capsules every 12 hours for 3 months.
Experimental Drug
Sponsors
Department of Pharmacy, Faculty of pharmacy, Silpakorn university
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: - Lennox-Gastaut syndrome diagnosis - 12 years and older - at least 2 antiepileptic drugs treatment (each at least 2 weeks) - seizure frequency more than 5 times per month for more than 1 year - learning or mental retardation
Exclusion criteria
Exclusion criteria: - do not have caregiver - not cooperated - pregnancy - during any hormone treatment - CHA2DS2-VASc at least 3 scores - history of stroke or myocardial infarction in 1 year - AST/ALT elevation 3 folds or more from upper limit of normal (ULN) in 3 months - abnormal renal function eGFR less than 30 mL/min - during penicillins treatment - any cancer diagnosis - progesterone allergy - any history of uncommon vaginal bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure at 1, 2 and 3 months seizure frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| seizure reduction at 1, 2 and 3 months sezure reduction percentage | — |
Countries
Thailand
Contacts
Public ContactPornsawan Mekhasingharak
Phramongkutklao Hospital
Outcome results
None listed