Phase
Condition
Friedreich's Ataxia
Dyskinesias
Spinocerebellar Disorders
Treatment
Artesunate Oral Product
Clinical Study ID
Ages 16-65 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with FA confirmed by genetic analysis
Weight of at least 50 kg
Compliant patient agreeing to come to all protocol visits
Signature of consent form by patient or parents of minor patient
Patients with no treatment during 30 days prior to the first intake of study drug,except cardiac, diabetes and spasticity treatments
Patients agreeing to use effective contraception for the duration of the study andup to 91 days after the last dose of the study treatment
Affiliation to an Health Insurance Scheme of beneficiary of such a scheme
Exclusion
Exclusion Criteria:
Patient under justice protection
Female patients
Abnormal biological values of renal and liver functions and cell blood count (CBC)
Progressive associated disease
Treatment interfering with iron transport within 30 days before first intake ofartesunate
Participation to another clinical trial
Hypersensitivity to artesunate or to any component of the drug
Blood potassium lower than normal value
QT / QTc interval > 450 ms on the ECG performed at inclusion
Congenital long QT syndrome
Family history of sudden cardiac death before the age of 50
Heart disease: ischemia or myocardial infarction, congestive heart failure orconduction disorder in the 6 months preceding inclusion
History of arrhythmia
Electrolyte imbalances: hypomagnesemia, hypocalcemia
Bradycardia (<50 beats per minute)
Acute neurological events within 6 months prior to inclusion
Study Design
Connect with a study center
Centre d'Investigation Clinique, hôpital Necker Enfants Malades
Paris,
FranceSite Not Available
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