Pharmacokinetic and Placental Transfer of Levetiracetam

NCT04117425 | Unknown

• 1 other identifier: CRC17036
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 hand. There is limited data on the pharmacokinetics (concentration study) and pharmacodynamics (efficacy and toxicity effects study) of levetiracetam in pregnant women. The few studies focus on few women and show very strong interindividual variability and a tendency to decrease total concentrations. Main objective: To develop a population pharmacokinetic model of levetiracetam during pregnancy. After the study, this model could be used to propose dose adjustments to maintain stable concentrations in pregnant women throughout pregnancy. Secondary objectives:

• Describe placental transfer during childbirth and during a medical termination of pregnancy
• Link the concentration and its variation in the individual to the effects of treatment

Conditions

Epilepsy in Pregnancy

Keywords

Epilepsy; pharmacokinetic; levetiracetam; placental transfer.

Outcome Measures

Primary Outcomes (1)

• Levetiracetam pharmacokinetics in pregnancy

  Levetiracetam concentrations as a function of time

  At delivery

Secondary Outcomes (9)

• Levetiracetam pharmacokinetics in pregnancy

  At inclusion

• Levetiracetam pharmacokinetics in pregnancy

  Until 17 weeks

• Levetiracetam pharmacokinetics in pregnancy

  Until 28 weeks

• Levetiracetam pharmacokinetics in pregnancy

  Until 6 week after delivery

• Exposure ratio

  At delivery

Study Arms (1)

Pregnant women

OTHER

40 Pregnant women and 10 Pregnant women that have a medical interruption of pregnancy who were already treated by levetiracetam. Blood collection at each trimester of pregnancy, delivery and post partum visit or at medical interruption. Collection of saliva at each trimester of pregnancy and post partum visit. Collection of cord blood and amniotic fluid at delivery or at medical interruption

Biological: biological collection

Interventions

biological collection BIOLOGICAL

Blood collection at each trimester of pregnancy, delivery and post partum visit or at medical interruption. Collection of saliva at each trimester of pregnancy and post partum visit. Collection of cord blood and amniotic fluid at delivery or at medical interruption.

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

hospital Cochin

Paris, 75014, France

RECRUITING

Related Publications (3)

• Pennell PB. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology. 2003 Sep 1;61(6 Suppl 2):S35-42. doi: 10.1212/wnl.61.6_suppl_2.s35.

  PMID: 14504308 BACKGROUND

• Tomson T, Palm R, Kallen K, Ben-Menachem E, Soderfeldt B, Danielsson B, Johansson R, Luef G, Ohman I. Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation. Epilepsia. 2007 Jun;48(6):1111-6. doi: 10.1111/j.1528-1167.2007.01032.x. Epub 2007 Mar 22.

  PMID: 17381438 BACKGROUND

• Westin AA, Reimers A, Helde G, Nakken KO, Brodtkorb E. Serum concentration/dose ratio of levetiracetam before, during and after pregnancy. Seizure. 2008 Mar;17(2):192-8. doi: 10.1016/j.seizure.2007.11.027. Epub 2008 Jan 3.

  PMID: 18180176 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean Marc Tréluyer, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Deborah Hirt, PhD

CONTACT

+33 1 58 41 32 83; deborah.hirt@aphp.fr

Charly Larrieu

CONTACT

+33 1 58 41 28 99; charly.larrieu@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Protocol to determine the optimal dose of levetiracetam during pregnancy

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: October 7, 2019
• Study Start: April 20, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)