Cause-based treatment of patients with therapy resistant early onset epilepsy

Phase 1

• Conditions: patients with epileptic encephalopathies; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001611-20-DE
• Lead Sponsor: niversity of Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-26
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

- highly active epilepsy (one or more seizures per day) with onset at 3 months of age or before - pharmo-resistance (2 or more anticonvulsive medications tried before with no effect) - max. 2 stable anticonvulsive drugs at study start
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- high-grade cardial rhythm disease - severe pathology of liver or renal function - severe change in blood counts or electrolytes - metabolic or lesional epilepsy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified