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Clinical Trials in the USA / NCT07082725
Recruiting Phase 3

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease (NPC)

NCT07082725 · tracked via the Priya Life Science USA tracker
Sponsor
Azafaros B.V.
Phase
Phase 3
Started
2025-06-30
Last updated
2026-09-18

Condition(s) studied

Niemann-Pick Type C Disease

Investigational drug(s) / intervention(s)

NizubaglustatPlacebo

Nizubaglustat: AZ-3102

Placebo: Matching placebo

Study summary

An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of Niemann-Pick type C disease

Eligibility

Sex
ALL
Min age
4 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Signed informed consent * Confirmed diagnosis of NPC disease * Patient is unable or unwilling to take miglustat, or is, in the opinion of the investigator, unsatisfactorily treated with miglustat * Male and female participants aged 4 years and older at the time of informed consent * Onset of neurological symptoms from 2 to 15 years * Disability level at Baseline: Ataxic disturbances with a total SARA score of ≥3 and ≤30 at Baseline * Female of childbearing potential who are sexually active willing to follow the contraceptive guidance * Male participants with a female partner of childbearing potential willing to follow the contraceptive guidance Exclusion Criteria: * A history of medical conditions other than NPC disease that, in the opinion of the Principal Investigator, would confound scientific rigor or the interpretation of results * Body weight of \<10 kg * The presence of another neurologic disease * The presence of moderate or severe hepatic impairment * The presence of moderate or severe renal impairment * Platelet count of \<100x10\^9/L * The dose of any anti-epileptic treatment(s) was not stable (required a change in dose within the previous 3 months) and/or a new anti-epileptic treatment (drug or procedure) was prescribed in the month before Baseline * Prior use of an investigational drug within the 3 months before Screening; or prior participation in a clinical study involving gene therapy or stem cell transplantation within 2 years prior to Screening * A positive serum pregnancy test (for women of childbearing potential) * Current treatment with miglustat, provided the patient has been using the recommended dose for most of the past 12 months AND is, in the opinion of the investigator, satisfactorily treated with miglustat. Any participants receiving miglustat are required to undergo a 1-month washout period before starting study medication

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
UCSF Children's Hospital and Research Center at Oakland Oakland California Recruiting
University of Minnesota Medical School Minneapolis Minnesota Not Yet Recruiting
Mayo Clinic Children's Center - PIN Rochester Minnesota Recruiting
Children's Medical Center Dallas Dallas Texas Recruiting
Lysosomal Rare Disorders Research and Treatment Center Fairfax Virginia Recruiting
Hospital de Niños de La Santisima Trinidad Córdoba Córdoba Province Recruiting
Women's and Children's Hospital North Adelaide South Australia Recruiting
Royal Melbourne Hospital Parkville Victoria Recruiting
Royal Children's Hospital Melbourne - PIN Parkville Victoria Recruiting
Instituto Fernandes Figueira Rio de Janeiro Rio de Janeiro Recruiting
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS Porto Alegre Rio Grande do Sul Recruiting
Hospital Pequeno Principe Curitiba Brazil Not Yet Recruiting
M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary Calgary Alberta Recruiting
University of Alberta Medical Genetics Clinic Edmonton Alberta Not Yet Recruiting
Centre Hospitalier de l'Universite de Montreal-1000 rue Saint-Denis Montreal Quebec Not Yet Recruiting
SphinCS GmbH Höchheim Germany Recruiting
Amrita Institute of Medical Sciences and Research Centre Ernākulam Kerala Recruiting
All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi National Capital Territory of Delhi Recruiting
JK Lone Hospital Jaipur Rajasthan Recruiting
Christian Medical College and Hospital Vellore Tamil Nadu Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy Recruiting
Hospital Universitario Dr. Jose Eleuterio González Monterrey Nuevo León Not Yet Recruiting
Centenario Hospital Miguel Hidalgo Aguascalientes Mexico Not Yet Recruiting
The Children's Hospital & the University of Child Health Lahore Lahore Punjab Province Not Yet Recruiting
ULS de Santo António, EPE - Centro Materno Infantil Norte Porto Porto District Recruiting
Hospital Universitario Vall d'Hebron - PPDS Barcelona Barcelona Recruiting
Hospital Infantil Universitario Niño Jesus - PIN Madrid Madrid Recruiting
Inselspital - Universitätsspital Bern Bern Canton of Bern Recruiting
Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi Adana Adana Recruiting
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Çankaya Ankara Recruiting
Ege Universitesi Tip Fakultesi Bornova İzmir Recruiting
Great Ormond Street Hospital London London Recruiting
University College London Hospitals (UCLH) London Middlesex Not Yet Recruiting
Royal Manchester Children's Hospital Manchester United Kingdom Not Yet Recruiting

More Azafaros B.V. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07082725 on ClinicalTrials.gov ↗ ← All trials in the USA