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Is there a therapeutic plasma level of cenobamate?

Is there a therapeutic plasma level of cenobamate?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030916
Enrollment
300
Registered
2022-12-29
Start date
2023-01-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G40.8 G40.2

Interventions

Group 1: Data from patients treated with cenobamate with regard to frequency of seizure attack, demographic data, data on side effects, plasma concentration of the anticonvulsant and other known covar

Sponsors

Epilepsiezentrum Kork
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Treatment with cenobamate

Exclusion criteria

Exclusion criteria: 1. Change in cenobamate dose within 7 days prior to determination of cenobamate serum concentration 2. Change in concomitant medication within 7 days prior to determination of serum cenobmate concentration 3. Inadequate documentation of seizure situation and tolerability 4. Non-epileptic seizures 5. Status epilepticus within the last 3 months 6. Data is NOT collected from the following patients: minors, the mentally handicapped, people with dementia, pregnant women, breastfeeding women or emergency patients.

Design outcomes

Primary

MeasureTime frame
Serum concentration of cenobamate which reduces the seizure attack by at least 50% over a period of at least 3 months.

Secondary

MeasureTime frame
Serum concentration of cenobamate which lead to a documentation of the two most common neurotoxic side effects, which are fatigue and / or dizziness

Countries

Germany

Contacts

Public ContactBernhard Steinhoff

Epilepsiezentrum Kork

BSteinhoff@epilepsiezentrum.de+49 7851 84 2250

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026