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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT01303406
Eligibility Criteria:
Inclusion Criteria:
* Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study
* Patients who in the opinion of the investigator are able to comply with the requirements of the study
* Body weight ≥ 25kg
* Negative urine pregnancy test
Exclusion Criteria:
* AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone
* Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine
* Parallel participation in another clinical drug trial
* Pregnancy or breast-feeding
* Abuse of drugs or alcohol
* Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT01303406
Study Brief:
Protocol Section:
NCT01303406