Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (IONIA)
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ClinicalTrials.gov Identifier: NCT00537680 |
Recruitment Status
:
Completed
First Posted
: October 1, 2007
Results First Posted
: December 29, 2011
Last Update Posted
: February 3, 2012
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Sponsor:
Santhera Pharmaceuticals
Information provided by (Responsible Party):
Santhera Pharmaceuticals
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 7, 2007 | ||||||
First Posted Date ICMJE | October 1, 2007 | ||||||
Results First Submitted Date | June 7, 2011 | ||||||
Results First Posted Date | December 29, 2011 | ||||||
Last Update Posted Date | February 3, 2012 | ||||||
Study Start Date ICMJE | December 2007 | ||||||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
ICARS [ Time Frame: baseline and 6 months ] International Cooperative Ataxia Rating Scale (ICARS): ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability. Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst). |
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Original Primary Outcome Measures ICMJE |
ICARS [ Time Frame: 6 months ] | ||||||
Change History | Complete list of historical versions of study NCT00537680 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia | ||||||
Official Title ICMJE | A Phase III Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients | ||||||
Brief Summary | This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period. | ||||||
Detailed Description | The study involves 6 clinic visits and upon completion the possibility to join a 12 months extension study where all patients will receive high dose Idebenone. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Friedreich's Ataxia | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
70 | ||||||
Original Estimated Enrollment ICMJE |
51 | ||||||
Actual Study Completion Date | April 2009 | ||||||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 8 Years to 17 Years (Child) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00537680 | ||||||
Other Study ID Numbers ICMJE | SNT-III-002 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Santhera Pharmaceuticals | ||||||
Study Sponsor ICMJE | Santhera Pharmaceuticals | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Santhera Pharmaceuticals | ||||||
Verification Date | February 2012 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |