The pharmacokinetic study of progesterone and allopregnanolone in refractory epilepsy : Phase II study

Phase 2

Completed

• Conditions: Drug resistant epilepsy; Neurosteroids, Progesterone, Drug resistant epilepsy

• Registration Number: TCTR20200710005
• Lead Sponsor: Department of Pharmacy, Faculty of pharmacy, Silpakorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Study Completion: 2021-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure at 1, 2 and 3 months seizure frequency

Secondary Outcome Measures

Name	Time	Method
seizure reduction at 1, 2 and 3 months sezure reduction percentage