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NCT00537680 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia
A Phase 3 study, sponsored by Santhera Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
NCT00537680: Completed Phase 3 study, sponsored by Santhera Pharmaceuticals.
NCT00537680 is a Phase 3 study that has completed, run by Santhera Pharmaceuticals. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00537680, a Phase 3 study, has completed, sponsored by Santhera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
Study 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.
Primary Outcome
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. Minimum score: 0, maximum score 100, higher score indicates greater impairment Calculation details: ICARS score at week 24 minus ICARS score basel
Interventions
- DRUG Placebo
- DRUG Idebenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00537680 record still lists
NCT00537680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00537680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00537680 about?
NCT00537680 is a clinical study titled "Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia". 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.
What is the current status of trial NCT00537680?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2007-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00537680?
The interventions under investigation include: Placebo (DRUG), Idebenone (DRUG).
Who is sponsoring clinical trial NCT00537680?
This trial is sponsored by Santhera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00537680's enrollment target sits among peer trials
70 1785th of 2000 higher than 208 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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