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Wirkung von Oxcarbazepin (Trileptal) auf den Kortikosteroid-Metabolismus - Pilotstudie

Wirkung von Oxcarbazepin (Trileptal) auf den Kortikosteroid-Metabolismus - Pilotstudie

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003913-15-AT
Enrollment
10
Registered
2007-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-10-08

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

Conditions

Oxcarbazepin, a widely-used antiepileptic treatment is evaluated with respect to Cortisol-degradation. Young adults and adults with oxcarbazepine monotherapy since at least 6 months and temporal lobe epilepsy are eligible to participate.Therefore 24-h-Urine has to be collected and degradation products are measured.

Interventions

Trade Name: Trileptal Product Name: Oxcarbazepin Pharmaceutical Form: Tablet

Sponsors

Medical University Innsbruck
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Young adults (>14 yrs, post-puberty) and adults with oxcarbazepine monotherapy since at least 6 months. Temporal-lobe epilepsy with no other cerebral malformations. Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: <14 years. Other types of epilepsy. Cerebral Malformations. combination therapy. Other endocrine disorders, especially endocrine or other disorders requiring cortisone therapy (e.g. mb. addison).

Design outcomes

Primary

MeasureTime frame
Main Objective: Degradation products of endogenous cortisol (e.g. 6OH-Cortisol) in 24-h-urine in patients with temporal lobe epilepsy with oxcarbazepine monotherapy.;Secondary Objective: ;Primary end point(s): total degradation markers of endogenous cortisol in patients.

Countries

Austria

Outcome results

None listed

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