Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00993967
Eligibility Criteria:
Inclusion Criteria:
* Completion of 52 weeks in study SNT-III-001
* Body weight ≥ 25 kg
* Negative urine pregnancy test
* Eligibility to participate in the present extension study as confirmed by investigator
Exclusion Criteria:
* Safety or tolerability issues arising during the course of SNT-III-001 which in the opinion of the investigator preclude further treatment with idebenone
* Clinically significant abnormalities of haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of SGOT, SGPT or creatinine
* Parallel participation in another clinical drug trial
* Pregnancy or breast-feeding
* Abuse of drugs or alcohol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Study:
NCT00993967
Study Brief:
Protocol Section:
NCT00993967