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Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00993967
First received: October 13, 2009
Last updated: August 28, 2012
Last verified: August 2012
History of Changes

October 13, 2009
August 28, 2012
June 2007
June 2012   (final data collection date for primary outcome measure)
  • Measures of safety and tolerability: nature and frequency of adverse events (AEs) [ Time Frame: Month 1, 3, 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
  • Measures of safety and tolerability: haematological and biochemical laboratory parameters [ Time Frame: Month 1, 3, 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
  • Measures of safety and tolerability: physical examinations and vital signs [ Time Frame: Month 1, 3, 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
  • Measures of safety and tolerability: electrocardiograms (ECGs) [ Time Frame: Month 1, 3, 6, 12, 18 and 24 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00993967 on ClinicalTrials.gov Archive Site
Absolute change in The International Cooperative Ataxia Rating Scale (ICARS) and Friedreich Ataxia Rating Scale (FARS) scores [ Time Frame: Baseline, Month 12 and month 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)
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.

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Freidreich's Ataxia
Drug: idebenone
Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
9 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Netherlands
 
NCT00993967
SNT-III-001-E
Yes
Santhera Pharmaceuticals
Santhera Pharmaceuticals
Not Provided
Principal Investigator: Nick Wood, Professor Dept of Molecular Neuroscience, Institute of Neurology. The National Hospital, University College London
Santhera Pharmaceuticals
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP