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Study to Assess the Safety and Tolerability of Idebenone in the (IONIA-E)

This study has been completed.
Sponsor:
Information provided by:
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00697073
First received: June 11, 2008
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
Results First Received: June 7, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Friedreich's Ataxia
Intervention: Drug: Idebenone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
High Dose Idebenone

Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)

Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)

Participant Flow:   Overall Study
    High Dose Idebenone  
STARTED     68  
COMPLETED     59  
NOT COMPLETED     9  
Withdrawal by Subject                 2  
Pregnancy                 1  
non compliance and other                 6  



  Baseline Characteristics
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Reporting Groups
  Description
High Dose Idebenone

Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)

Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)

Baseline Measures
    High Dose Idebenone  
Number of Participants  
[units: participants]
 		  68  
Age  
[units: participants]
 		 
<=18 years     68  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  14.0  ± 2.72  
Gender  
[units: participants]
 		 
Female     36  
Male     32  
Region of Enrollment  
[units: participants]
 		 
United States     68  



  Outcome Measures

1.  Primary:   Change in ICARS   [ Time Frame: baseline and 12 months ]
  Show Outcome Measure 1

2.  Secondary:   FARS (Friedreich’s Ataxia Rating Scale)   [ Time Frame: baseline and 12 Months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Nature and Frequency of Adverse Events   [ Time Frame: 12 Months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr Thomas Meier
Organization: Santhera
phone: +41 61 906 8964
e-mail: thomas.meier@santhera.com


Publications of Results:


Responsible Party: Thomas Meier, PhD / Chief Scientific Officer, Santhera Pharmaceuticals (Switzerland) Ltd.
ClinicalTrials.gov Identifier: NCT00697073     History of Changes
Other Study ID Numbers: SNT-III-002-E
Study First Received: June 11, 2008
Results First Received: June 7, 2011
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration