Efficacy and safety of oral micronized progesterone that converts to allopregnanolone as an adjunctive treatment in refractory status epilepticus (Phase IIa study)
Phase 2
Completed
- Conditions
- Refractory status epilepticus (RSE) patient
- Registration Number
- TCTR20200717002
- Lead Sponsor
- Phramongkutklao Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
1.Adults, age 18â€80 years old
2.Diagnosed with either convulsive or non-convulsive RSE
3.Receiving standard AED treatment, including intravenous midazolam, for longer than 60 minutes
Exclusion Criteria
1.Pregnancy or lactation
2.Serious medical problems; renal failure on dialysis, metastatic cancer, active thromboembolism, active bleeding, elevated transaminase enzymes ≥ five times of normal value (> 160 U/L), blood pressure lower than 80/50 mmHg
3.Absolute NPO (as the studied drug was an enteric tubal formulation)
4.Receiving drugs with potential major interaction with progesterone (e.g. estrogen, edoxaban, and venetoclax)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of the first RSE termination 5 days EEGs
- Secondary Outcome Measures
Name Time Method hospital and ICU stays hospital stay duration,Mortality rate hospital stay mortality rate and in-hospital mortality rate compared with RSE control patients,Midazolam dose termination of RSE of 5 days elapsed total dose of midazolam,safety hospital stay vital signs, clinical adverse events, abnormal laboratories values