A Phase III Open-Label, Single-Group Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients - MICONOS EXTENSION

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001646-40-DE

Enrollment

232

Registered

2007-04-25

Start date

2007-06-11

Completion date

Unknown

Last updated

2017-07-17

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

Conditions

Friedrich's Ataxia MedDRA version: 12.0 Level: LLT Classification code 10017374 Term: 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: • Completion of 52 weeks in study SNT-III-001 • Body weight = 25kg • Negative urine pregnancy test • Eligibility to participate in the present extension study as confirmed by the investigator 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To gather long-term data on the safety and tolerability of idebenone in Friedreich’s Ataxia patients ;Secondary Objective: • To explore the effect of idebenone after longer term administration on neurological symptoms and signs as assessed by the International Cooperative Ataxia Rating Scale (ICARS) and the Friedreich’s Ataxia Rating Scale (FARS). ;Primary end point(s): • Measures of safety and tolerability - nature and frequency of AEs - haematological and biochemical parameters - physical examinations and vital signs - ECGs	—

Measure

Time frame

Main Objective: • To gather long-term data on the safety and tolerability of idebenone in Friedreich’s Ataxia patients ;Secondary Objective: • To explore the effect of idebenone after longer term administration on neurological symptoms and signs as assessed by the International Cooperative Ataxia Rating Scale (ICARS) and the Friedreich’s Ataxia Rating Scale (FARS). ;Primary end point(s): • Measures of safety and tolerability - nature and frequency of AEs - haematological and biochemical parameters - physical examinations and vital signs - ECGs

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Countries

Austria, Belgium, France, Germany, Netherlands, United Kingdom

Outcome results

None listed

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