Status:
UNKNOWN
Pharmacokinetic and Placental Transfer of Levetiracetam
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Epilepsy in Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Hypotheses: The treatment of epilepsy during pregnancy is difficult because of the risk of anti-epileptic drugs on the one hand and the risk of destabilization of epilepsy in the mother on the other h...
Detailed Description
Methodology: Are included by the neurology service, pregnant women which are already under levetiracetam and / or obstetric gynecology services for her treatment of epilepsy, pregnant women at first c...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04117425
Start Date
April 20 2022
End Date
September 1 2023
Last Update
September 27 2022
Active Locations (1)
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1
hospital Cochin
Paris, France, 75014