Efficacy and tolerability of adjunctive treatment of epilepsy patients with cenobamate: An observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027568

Enrollment

200

Registered

2022-03-02

Start date

2022-01-02

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

G40.2

Interventions

Group 1: Systematic assessment at baseline and follow-up (3-, 6- and 12-months) of treatment efficacy and tolerability using seizure diaries, standardized questionnaires, clinical examinations and lab

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with partial-onset seizures with or without secondary generalization who are drug resistant to at least 2 previously used antiepileptic drugs 2. Add-on treatment with cenobamate in clinical routine 3. Written informed consent to participate in the trial and ability to adhere to the protocol

Exclusion criteria

Exclusion criteria: 1. Genetic epilepsy 2. Drug resistance not yet established

Design outcomes

Primary

Measure	Time frame
To determine the treatment efficacy and tolerability of adjunctive treatment with cenobamate.	—

Secondary

Measure	Time frame
To determine the effect of adjunctive cenobamate treatment on (i) laboratory test results and (ii) bone density in the hip and spine.	—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 5, 2026