Phase 3
Completed N=200
Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)
Freidreich's Ataxia
Source: ClinicalTrials.gov NCT00993967 ↗
Enrolled (actual)
200
Serious AEs
24.5%
Results posted
Mar 2018
Primary outcomePrimary: Measures of Safety and Tolerability: Nature and Frequency of Adverse Events (AEs) — 188; 109; 8; 54 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measures of Safety and Tolerability: Nature and Frequency of Adverse Events (AEs) |
188; 109; 8; 54; 1; 48 | — |
| PRIMARY Absolute Change in The International Cooperative Ataxia Rating Scale (ICARS) |
1.41; 2.88 | — |
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
Data sourced from ClinicalTrials.gov (NCT00993967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.