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Study identifier: NCT05163288 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C

Condition: Niemann-Pick Disease, Type C  ·  Sponsor: IntraBio Inc

PhasePhase 3
Planned participants53
Who can joinAll sexes, 4 Years to no upper limit
Healthy volunteersNo

About this study

A pivotal, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of Niemann Pick disease type C (NPC). The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care. Following this randomized, double-blind, placebo-controlled "Parent Study", an extension phase is conducted for (1) patients who completed the "Parent Study" and (2) patients who are enrolled directly into the Extension Phase. Currently, the Extension Phase provides patients with 3 years of open-label treatment.

This description comes directly from the study's public registry record.

Talk to the study team

Michael Strupp, MD  ·  +44 8081 641283  ·  mstrupp@intrabio.com

Taylor Fields  ·  +44 8081 641283  ·  tfields@intrabio.com

Always discuss trial participation with your own doctor first.

Locations (14)

Mayo ClinicRochester, Minnesota, United StatesCompleted
The Royal Melbourne HospitalParkville, Victoria, AustraliaActive Not Recruiting
First Faculty of Medicine, Charles University Hospital PraguePrague, CzechiaActive Not Recruiting
University of GiessenGiessen, GermanyActive Not Recruiting
University of HamburgHamburg, GermanyCompleted
SphinCS - Institute of Clinical Science in Lysosomal Storage DisordersHöchheim, GermanyActive Not Recruiting
Ludwig Maximilian University of MunichMünchen, GermanyNot Yet Recruiting
University Hospital MünsterMünster, GermanyActive Not Recruiting
Amsterdam UMCAmsterdam, NetherlandsRecruiting
Comenius University in BratislvaBratislava, SlovakiaActive Not Recruiting
University Hospital Bern InselspitalBern, SwitzerlandActive Not Recruiting
Great Ormond Street HospitalLondon, United KingdomActive Not Recruiting

+ 2 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05163288