Wirkung von Oxcarbazepin (Trileptal) auf den Kortikosteroid-Metabolismus - Pilotstudie
Phase 1
- 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.
- Registration Number
- EUCTR2007-003913-15-AT
- Lead Sponsor
- Medical University Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 10
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
<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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method