A Phase III double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of Friedreich's Ataxia patients. - MICONOS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004083-22-GB

Enrollment

204

Registered

2005-10-17

Start date

2006-04-25

Completion date

Unknown

Last updated

2017-07-10

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

Conditions

Friedreich's Ataxia

Interventions

Product Name: Idebenone Product Code: SNT-MC17 Pharmaceutical Form: Tablet INN or Proposed INN: Idebenone Current Sponsor code: SNT-MC17 Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Documented diagnosis of FRDA with confirmed FRDA mutations •Patients 8 years of age or older at time of enrolment •Patients with body weight = 25kg •Patients who in the opinion of the investigator are able to comply with the requirements of the study •Negative urine pregnancy test at screening (women of childbearing potential) 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: •Treatment with idebenone or coenyzme Q within 1 month •Pregnancy and/or breast-feeding •Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT or creatinine •Past or present history of abuse of drugs or alcohol

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Neurological To compare the efficacy of 12 months’ treatment with three different doses of Idebenone with that of placebo on neurological impairment as assessed by the ICARS scale ;Secondary Objective: Secondary Cardiological To compare the efficacy of 12 months’ treatment with three different doses of Idebenone with that of placebo on left ventricular mass index To compare the effect of 12 months’ treatment with three different doses of Idebenone with that of placebo on myocardial function in order to rule out significant deterioration of cardiac function To compare the effect of 12 months’ treatment with three different doses of Idebenone with that of placebo on performance in an exercise test Secondary Neurological To compare the efficacy of 12 months’ treatment with three different doses of Idebenone with that of placebo on neurological function as assessed by the FARS scale ;Primary end point(s): Neurological Change in International Cooperative Ataxia Rating Scale (ICARS) from baseline assessment to Week 52	—

Measure

Time frame

Main Objective: Primary Neurological To compare the efficacy of 12 months’ treatment with three different doses of Idebenone with that of placebo on neurological impairment as assessed by the ICARS scale ;Secondary Objective: Secondary Cardiological To compare the efficacy of 12 months’ treatment with three different doses of Idebenone with that of placebo on left ventricular mass index To compare the effect of 12 months’ treatment with three different doses of Idebenone with that of placebo on myocardial function in order to rule out significant deterioration of cardiac function To compare the effect of 12 months’ treatment with three different doses of Idebenone with that of placebo on performance in an exercise test Secondary Neurological To compare the efficacy of 12 months’ treatment with three different doses of Idebenone with that of placebo on neurological function as assessed by the FARS scale ;Primary end point(s): Neurological Change in International Cooperative Ataxia Rating Scale (ICARS) from baseline assessment to Week 52

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Countries

Austria, Belgium, France, Germany, United Kingdom

Outcome results

None listed

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