An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

May 21, 2021

Primary Completion Date

September 12, 2023

Study Completion Date

October 5, 2023

Conditions
Primary Mitochondrial Myopathy
Interventions
DRUG

Mavodelpar

Once daily

DRUG

Placebo

Once daily

Trial Locations (41)

1023

University of Auckland, Auckland

1082

Semmelweis University Insitute of Genomics and Rare Disorders, Budapest

2065

Royal North Shore Hospital, St Leonards

2100

Rigshospitalet, University of Copenhagen, Copenhagen

3004

The Alfred Hospital, Melbourne

5000

PARC Clinical Research, Adelaide

7623

University of Pécs Clinical Centre, Department of Neurology, Pécs

8036

Hospital Clinic de Barcelona, Barcelona

10032

Columbia University Irving Medical Center, New York

12808

General University Hospital in Prague, Prague

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

The Children's Hospital of Philadelphia, Philadelphia

20126

"Fondazione IRCCS Istituto Neurologico Carlo Besta UOC Genetica Medica e Neurogenetica", Milan

32608

Myology Institute, University of Florida, Gainesville

40139

IRCCS Istituto delle Scienze Neurologiche, Bologna

44308

Akron Children's Hospital, Akron

46026

Hospital Universitari i Politècnic La Fe, Valencia

49933

Centre Hospitalier Universitaire d' Angers, Angers

53127

University Hospital Bonn Clinic and Polyclinic for Neurology, Bonn

56126

Azienda Ospedaliero-Universitaria Pisana Dipartimento di specialita' mediche UOC Neurologia, Pisa

59037

Hôpital Roger Salengro, Lille

67200

Hôpitaux Universitaires de Strasbourg, Strasbourg

69599

Hôpital Neurologique Pierre Wertheimer, Bron

75390

University of Texas SouthWestern Medical Center, Dallas

75651

Hôpital Pitié-Salpêtrière, Paris

77025

Centre for the Treatment of Pediatric Neurodegenerative Disease, University of Texas McGovern Medical School, Houston

80336

Medical Center of the University of Munich Friedrich Baur Institute at the Neurological Clinic and Polyclinic, Munich

92093

University of California, San Diego, La Jolla

98125

A.O.U Policlinico di Messina U.O.C Neurologia e Malattie Neuromuscolari, Messina

02114

Massachusetts General Hospital, Boston

3000B

University Hospital Leuven, Leuven

T2E 7Z4

M.A.G.I.C. Clinic (Metabolics and Genetics in Calgary), Calgary

V5Z 1M9

Adult Metabolic Diseases Clinic, Vancouver General Hospital, Vancouver

06202

CHU de Nice, Nice

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Neurophysiopathology Unit, Rome

6525EX

Radboud Universitair Medisch Centrum, Nijmegen

N-5053

Haukeland University Hospital, Bergen

08041

Hospital Universitario 12 de Octubre, Madrid

WC1N 3BG

Queen Square Centre for Neuromuscular Diseases, London

M6 8HD

Salford Royal NHS Foundation Trust, Salford

NE1 4LP

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

All Listed Sponsors
lead

Reneo Pharma Ltd

INDUSTRY