(+) Epicatechin to Treat Friedreich's Ataxia
Completed · Phase 2
Conditions studied: Friedreich's Ataxia
In brief
This 24-week study will test the safety and effectiveness of synthetically produced (+) Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.
Key facts
- Study ID
- NCT02660112
- Run by
- Ralitza Gavrilova
- People needed
- 10
- Starts
- 2016-09-01
- Expected to finish
- 2018-12-30
- Last updated by the study team
- 2019-12-05
Who can join
Age: 10 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of Friedreich's Ataxia (FA) by Frataxin genetic testing and/or Frataxin enzyme analysis
- Between age 10 and 50 years of age, inclusive
- Body weight of 25 kilograms or higher
- Minimum of one affected organ (cardiac or neurological) system, as evidenced by clinical signs/symptoms
- Disease duration ≤7 years, based on onset date of FA symptoms
- Has no known contraindication to gadolinium contrast such as severe allergy or Glomerular Filtration Rate <30 ml/min/m\^2.
- Has no known contraindication to non-contrast Magnetic Resonance Imaging (MRI) evaluation such as pacemaker or magnetically active metal fragments.
- Women of childbearing age must:
- Have a negative pregnancy human chorionic gonadotropin test prior to receiving study drug.
- Agree to use contraception for the duration of the study drug dosing, plus 1 month after completion of the study.
You may not qualify if…
- Advanced cardiac failure, New York Heart Association (NYHA) Classification Scale-Class IV (advanced stage heart failure)
- Clinically significant comorbidities that may also lead to cardiomyopathy, for example long standing hypertension, familial cardiomyopathy.
- Clinically significant comorbidities that would, in the opinion of the investigators, compromise the interpretation of test results.
- Pregnant, breast-feeding or planning to become pregnant during study timeframe.
- Patients with contraindications to regadenoson, i. e. second- or third-degree atrioventricular (AV) block or sinus node dysfunction. Has received an investigational drug within thirty (30) days of baseline visit.
- Thrombocytopenia (<125 x 10\^9/Liter) or prolonged Prothrombin Time/Partial Thromboplastin Time (PT/PTT) at baseline.
- Clinically significant hypotension (systolic blood pressure <90) due to heart failure or other conditions.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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