Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

March 30, 2021

Primary Completion Date

April 19, 2024

Study Completion Date

April 19, 2024

Conditions
Charcot-Marie-Tooth Disease
Interventions
DRUG

(RS)-baclofen, naltrexone hydrochloride and D-sorbitol

oral fixed dose combination

DRUG

Placebo

liquid oral solution

Trial Locations (50)

3000

Universitaire Ziekenhuizen Leuven, Leuven

10032

Colombia University Department of Neurology, New York

13385

Service de Neurologie et Maladies Neuromusculaires, CHU de Marseille - Hopital La Timone, Marseille

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

16132

Azienda Ospedaliera Universitaria San Martino Universita Degli Studi di Genova Clinica Neurologica, Genova

27514

UNC Department of Neurology Peripheral Neuropathy Center, Chapel Hill

28040

Hospital Universitario Clinico San Carlos, Madrid

28207

Atrium Health Neurosciences Institute, Charlotte

32610

University of Florida Clinical Research Center, Gainesville

32803

Advent Health Medical Group Neurology Orlando, Orlando

33076

Centre de reference des maladies neuromusculaires AOC Hopital Pellegrin CHU de Bordeaux, Bordeaux

33136

University of Miami Leonard M. Miller School of Medicine, Miami

37134

University Hospital GB Rossi UOC Neurologia B, AOUI Verona Department of Neuroscience, Biomedicine and Movement Sciences, Verona

41013

Hospital Universitario Virgen del Rocío, Seville

43210

The Ohio State University Wexner Medical Center, Columbus

46026

Hospital Universitario y Politécnico La Fé, Valencia

48149

University Hospital Muenster UKM Department of Neurology, Münster

49933

Centre de Reference des Maladies Neuromusculaires AOC Service de Neurologie, CHU d'Angers, Angers

52662

Sheba Medical Center, Ramat Gan

55414

University of Minnesota Health, Minneapolis

59037

CHU de Lille Hôpital Salengro, Lille

65212

MU Health Care Neurology and Sleep Disorders Clinic, Columbia

66205

University of Kansas Medical Center Research Institute, Fairway

67098

Centre d'investigation Clinique CHU de Strasbourg Hopital de Hautepierre, Strasbourg

72076

Universitätsklinikum Tübingen Crona Kliniken Neuromuskuläres Zentrum, Tübingen

75013

Association lnstitut de Myologie Hopital Pitie-Salpetriere Service de Neuro-Myologie, Paris

78759

National Neuromuscular Research Institute, Austin

80131

University of Naples Federico II, Naples

90048

Cedars-Sinai Medical Center, Los Angeles

90095

UCLA Department of Psychiatry and Biobehavioral Sciences, Los Angeles

91120

Hadassah Ein Kerem University Medical Center Department of Neurology, Jerusalem

95817

UC Davis Health Department of Physical Medicine and Rehabilitation, Sacramento

97477

Oregon Neurology, Springfield

98125

"Azienda Ospedaliera Universitaria Policlinico G. Martino di Messina", Messina

98195

Neurology Clinic at University of Washington Medical Center, Seattle

99202

Providence St. Luke's Rehabilitation Medical Center, Spokane

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

06053

Hospital for Special Care, New Britain

02114

Massachusetts General Hospital Neuromuscular Diagnostic Center, Boston

07601

Hackensack Meridian Health Hackensack University Medical Center, Hackensack

K1Y 4E9

Ottawa Hospital Research Institute- Neuromuscular Research Centre, Ottawa

M5G 2C4

UHN Toronto General Hospital Krembil Neuroscience Centre, Toronto

G7H 5H6

CIUSS de Saguenay-Lac-Saint-Jean Centre d'etudes Cliniques, Chicoutimi

H3A 2B4

Montreal Neurological Institute and Hospital-Clinical Research Unit, Montreal

G1J 1Z4

CHU de Quebec-Universite Laval- Hopital Enfant-Jesus, Québec

DK-1200

Rigshospitalet, University of Copenhagen Copenhagen Neuromuscular Center, Copenhagen

D-52074

University Hospital RWTH Aachen, Department of Neurology and Institute for Neuropathology, Aachen

D-37075

University Medical Centre Goettingen, Dept. of Clinical Neurology, Göttingen

D-80336

Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik Ludwig-Maximilians-Universität, München

00133

Tor Vergata University of Rome, Rome

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Worldwide Clinical Trials

OTHER

lead

Pharnext S.C.A.

OTHER