A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of GM1 Gangliosidosis or GM2 Gangliosidosis

PHASE3RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

November 4, 2027

Study Completion Date

November 4, 2027

Conditions
Gangliosidoses, GM2Gangliosidosis, GM1
Interventions
DRUG

AZ-3102

Nizubaglustat

DRUG

Placebo

Placebo

Trial Locations (31)

1250

NOT_YET_RECRUITING

Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi, Adana

3010

NOT_YET_RECRUITING

Inselspital - Universitätsspital Bern, Bern

3052

NOT_YET_RECRUITING

Royal Children's Hospital Melbourne - PIN, Parkville

5006

NOT_YET_RECRUITING

Women's and Children's Hospital, North Adelaide

6500

NOT_YET_RECRUITING

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi, Çankaya

8035

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

13005

NOT_YET_RECRUITING

AP-HM- Hôpital de La Timone, Marseille

20133

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

28009

RECRUITING

Hospital Infantil Universitario Niño Jesus - PIN, Madrid

35100

NOT_YET_RECRUITING

Ege Universitesi Tip Fakultesi, Bornova

55905

NOT_YET_RECRUITING

Mayo Clinic Children's Center - PIN, Rochester

75012

NOT_YET_RECRUITING

AP-HP - Hôpital Armand Trousseau, Paris

94609

NOT_YET_RECRUITING

Children's Hospital and Research Center at Oakland, Oakland

110029

NOT_YET_RECRUITING

All India Institute of Medical Sciences (AIIMS) - New Delhi, New Delhi

302004

NOT_YET_RECRUITING

JK Lone Hospital, Jaipur

400012

NOT_YET_RECRUITING

Seth G S Medical College and K E M Hospital, Mumbai

682041

NOT_YET_RECRUITING

Amrita Institute of Medical Sciences and Research Centre, Ernākulam

22030-7404

NOT_YET_RECRUITING

Lysosomal Rare Disorders Research and Treatment Center, Fairfax

B1629AHJ

NOT_YET_RECRUITING

Hospital Universitario Austral, Ciudad Autónoma Buenos Aires

X5004 ASL

NOT_YET_RECRUITING

Hospital de Niños de La Santisima Trinidad, Córdoba

22250-020

NOT_YET_RECRUITING

Instituto Fernandes Figueira, Rio de Janeiro

90560-030

NOT_YET_RECRUITING

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre

Unknown

NOT_YET_RECRUITING

Hospital Pequeno Principe, Curitiba

NOT_YET_RECRUITING

Great Ormond Street Hospital NHSFT, London

T3B 6A8

NOT_YET_RECRUITING

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

T6G 2B7

NOT_YET_RECRUITING

University of Alberta Medical Genetics Clinic, Edmonton

H2X 0C1

NOT_YET_RECRUITING

Centre Hospitalier de l'Universite de Montreal-1000 rue Saint-Denis, Montreal

4050-651

RECRUITING

ULS de Santo António, EPE - Centro Materno Infantil Norte, Porto

1649-035

RECRUITING

ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS, Lisbon

416 50

RECRUITING

Sahlgrenska universitetssjukhuset Östra, Gothenburg

WC1N 3BG

NOT_YET_RECRUITING

University College London Hospitals (UCLH), London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Azafaros A.G.

INDUSTRY