NCT05515536RecruitingPhase 3
Long-Term Open-Label Study to Assess the Safety and Efficacy of Vatiquinone in Patients With Friedreich Ataxia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Nov 2026
Brief summary (registry, in English)
To assess the long-term safety of vatiquinone in subjects with FA previously exposed to vatiquinone
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 27 Sept 2024
- Start date
- 22 Mar 2023
- Lead sponsor
- PTC Therapeutics Inc.
- Diseases
- Friedreich ataxia
- NCT number
- NCT05515536
- EU CT number
- 2024-516505-23-00
- EudraCT number
- 2022-002668-65
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 34
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- Current participation in any other interventional study
- Pregnancy or breastfeeding
Who the study is looking for
- Subjects with FA who completed and directly rolled over from a previous vatiquinone clinical study.
- Males and females of childbearing potential must be willing to use an effective method of contraception (eg, implants, injectables, transdermal patch, combined oral contraceptives, barrier methods, and intrauterine devices) from the time consent is signed until 30 days after last dose of study drug or Early Termination Visit. Male subjects must agree not to donate sperm during the study and for at least 30 days after the last dose of study drug or Early Termination Visit. Note: Double-barrier method (ie, condom with spermicide) is required if no other methods of contraception are in use.
- Subject provides consent to participate.
Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.