NCT04921930CompletedPhase 1/2
Evaluation of the Effect of Artesunate in Friedreich Ataxia (FA)
Evaluation of the Effect of Artesunate in Friedreich Ataxia (FA) Phase I-II Efficacy-Toxicity of Artesunate in Friedreich Ataxia
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
This dose-escalation study is aimed at investigating a novel application for artesunate in the treatment of Friedreich ataxia. It will evaluate this novel application of oral artesunate using a surrogate biological marker as primary endpoint in a phase I-II open trial
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 31 May 2021
- Start date
- 6 May 2022
- Primary completion date
- 17 Apr 2024
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Friedreich ataxia
- NCT number
- NCT04921930
- EudraCT number
- 2021-000171-36
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 20
- From 6 May 2022 to the primary completion date, 17 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment interfering with iron transport within 30 days before first intake of artesunate
- Acute neurological events within 6 months prior to inclusion
Other illness
- Progressive associated disease
- Hypersensitivity to artesunate or to any component of the drug
- Heart disease: ischemia or myocardial infarction, congestive heart failure or conduction disorder in the 6 months preceding inclusion
- History of arrhythmia
Lab values
- Abnormal biological values of renal and liver functions and cell blood count (CBC)
- Blood potassium lower than normal value
- QT / QTc interval \> 450 ms on the ECG performed at inclusion
- Congenital long QT syndrome
Age
- Family history of sudden cardiac death before the age of 50
Other
- Patient under justice protection
- Female patients
- Participation to another clinical trial
- Electrolyte imbalances: hypomagnesemia, hypocalcemia
- Bradycardia (\<50 beats per minute)
Who the study is looking for
- 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 and up to 91 days after the last dose of the study treatment
- Affiliation to an Health Insurance Scheme of beneficiary of such a scheme
Age in the registry: 16 years to 65 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre d'Investigation Clinique, hôpital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.