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ACTIVE NOT RECRUITING
NCT05515536
PHASE3

A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia

Sponsor: PTC Therapeutics

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess the long-term safety of vatiquinone in participants with Friedreich ataxia (FA) previously exposed to vatiquinone.

Official title: Long-Term Open-Label Study to Assess the Safety and Efficacy of Vatiquinone in Patients With Friedreich Ataxia

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2022-12-08

Completion Date

2027-12-31

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

DRUG

Vatiquinone

Vatiquinone will be administered per dose and schedule specified in the arm.

Locations (14)

UCLA

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States

University of South Florida

Tampa, Florida, United States

University of Iowa

Iowa City, Iowa, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Murdoch Children's Research Institute

Parkville, Victoria, Australia

University of Campinas (UNICAMP) - School of Medical Sciences, Dept of Neurology

São Paulo, Brazil

Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)

Montreal, Quebec, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Hôpital Pitié-Salpêtrière, Institut du Cerveau (Paris Brain Institute)

Paris, France

Department of Neurology and Hertie-Institute for Clinical Brain Research German Center of Neurodegenerative Diseases (DZNE)

Tübingen, Germany

Ospedale Pediatrico Bambino Gesu' IRCCS

Roma, Italy

CBR Neurogenetic Research Clinic, University of Auckland

Auckland, New Zealand

Hospital Sant Joan de Déu Barcelona Unidad de Enfermedades Neuromusculares

Barcelona, Spain