TCTR20200717002
Completed
Phase 2
Efficacy and safety of oral micronized progesterone that converts to allopregnanolone as an adjunctive treatment in refractory status epilepticus (Phase IIa study)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Refractory status epilepticus (RSE) patient
- Sponsor
- Phramongkutklao Hospital
- Enrollment
- 6
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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