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Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients (IONIA-E)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00697073
First received: June 11, 2008
Last updated: May 24, 2013
Last verified: May 2013
Results First Received: June 7, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Friedreich's Ataxia
Intervention: Drug: Idebenone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 ]

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

3.  Secondary:   Nature and Frequency of Adverse Events   [ Time Frame: 12 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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: Santhera Pharmaceuticals
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: May 24, 2013