EUCTR2020-004878-22-FR
Active, not recruiting
Phase 1
Pharmacokinetic and Placental Transfer of Levetiracetam - EPICEINTE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Epilepsy in pregnancy
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Pregnant women of childbearing age who are pregnant
- •\- Age \=18 years
- •\- Women with epilepsy treated with levetiracetam in monotherapy or combination
- •\- Affiliated to a social security scheme (or entitled)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 50
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Women treated with antiepileptics for pathology other than epilepsy
- •\- Women treated with a combination of more than 3 antiepileptics
- •\- Severe anemia
- •\- Renal failure (moderate to severe)
- •\- Hepatic impairment (moderate to severe)
- •\- Alcohol and/or recreational drug use
- •\- Trend towards non\-compliance with treatment
- •\- Inability to maintain a Crisis Observation Workbook
- •\- Suicidal Ideas
- •\- Uncontrolled thyroid disease
Outcomes
Primary Outcomes
Not specified
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