Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT)

PHASE3CompletedINTERVENTIONAL
Enrollment

323

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

March 31, 2018

Study Completion Date

August 31, 2018

Conditions
Charcot-Marie-Tooth Disease Type 1A
Interventions
DRUG

PXT3003 dose 1

Liquid oral solution, 5 ml twice a day, morning and evening with food

DRUG

PXT3003 dose 2

Liquid oral solution, 5 ml twice a day, morning and evening with food

DRUG

placebo

Liquid oral solution, 5 ml twice a day, morning and evening with food

Trial Locations (30)

10032

Peripheral Neuropathy Center, Neurological Institue Building, Columbia University Medical Center, New York

32610

Department of Neurology, McKnight Brain Institute, Gainesville

43210

Ohio State University, Columbus

55455

Department of Neurology, University of Minnesota, Minneapolis

66160

University of Kansas Medical Center, Kansas City

90048

Department of Neurology, Cedars-Sinai Medical Center, Los Angeles

06053

Hospital for Special Care, New Britain, New Britain

02115

Brigham and Women's Hospital, Boston

48109-5322

University of Michigan Health System, Ann Arbor

63104-1027

Department of Neurology and Psichiatry, Saint Louis University, St Louis

99202-1330

Saint Luke's Rehabilitation Institute, Spokane

Unknown

Departement of Neurology, UZ Leuven, Leuven

Centre de Référence des Maladies Neuromusculaires, Hôpital Swynghedauwl, CHU de Lille, Lille

Centre de Référence des Neuropathies Périphériques Rares, Hôpital Dupuytren, CHU Limoges, Limoges

Service de Neurologie et du Sommeil, CHU Lyon Sud, Lyon

Centre de Référence des Maladies Neuromusculaires, Pôle des Neurosciences Clinique, CHU la Timone, Marseille

Centre de Référence des Maladies Neuromusculaires; Hôtel Dieu, CHU de Nantes, Nantes

Service de Neurologie, Hôpital Kremlin Bicêtre, Paris

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

Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen

Department of Neurology, Ludwig-Maximillian University, Munich, Munich

Department for Sleep Medicine and Neuromuscular, University Hospital Münster, Münster

Departement of Neurology, Academic Medical Center, Amsterdam

Department of neurology, Hospital Univesitario de Bellvitge, Barcelona

Servicio de Neurologia, Hospital Universitario La Paz, Madrid

Centro de Diagnostico y Tratamiento, Hospital Universitario Virgen del Rocio, Seville

Servicio de Neurologia, Hospital Univesitari i Politécnic La Fe, Valencia

G1J 1Z4

University Hospital of Quebec, Québec

M6 8HD

Department of Neurology, Salford Royal NHS Foundation Trust, Salford

DD1 9SY

Ninewells Hospital and Medical School, Dundee

All Listed Sponsors
lead

Pharnext S.C.A.

OTHER

NCT02579759 - Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT) | Biotech Hunter | Biotech Hunter