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Niemann-Pick Diseases clinical trials

View clinical trials related to Niemann-Pick Diseases.

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NCT ID: NCT05758922 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C

Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZ-3102 in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease

RAINBOW
Start date: April 24, 2023
Phase: Phase 2
Study type: Interventional

This phase 2 is a randomized, double-blind, placebo controlled, 12 weeks study with daily oral administration of AZ-3102 aiming to evaluate the safety and pharmacokinetic (PK) profile in GM2 Gangliosidosis and Niemann-Pick type C disease (NP-C) patients. If approved by the country health authorities, a double-blind extension period will be proposed to the patients who complete the 12-week study.

NCT ID: NCT05163288 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C

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

Start date: June 30, 2022
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04860960 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C1

Phase 3 Study to Evaluate Intravenous Trappsol(R) Cyclo(TM) in Pediatric and Adult Patients With Niemann-Pick Disease Type C1

TransportNPC
Start date: July 20, 2021
Phase: Phase 3
Study type: Interventional

A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1). The objective of this study is to evaluate the safety, tolerability and efficacy of 2000 mg/kg dose of Trappsol Cyclo (hydroxypropyl betacyclodextrin) administered intravenously compared to standard of care. An open-label sub-study in countries following European Medicines Agency (EMA) guidance will enroll asymptomatic or symptomatic patients from infancy up to age 3 to evaluate safety in that population.

NCT ID: NCT03893071 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C1

Open-Label Study of Long-Term Safety and Efficacy of Intravenous Trappsol Cyclo (HPβCD) in Niemann-Pick Disease Type C

Start date: May 23, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to provide continued access to treatment for NPC-1 after participation and completion of the Phase I trial CTD-TCNPC-101, when administered at doses of 1500 mg/kg and 2500 mg/kg by slow IV infusion over a period of 8 to 9 hours every two weeks.

NCT ID: NCT03201627 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C1

Study of Lithium Carbonate to Treat Niemann-Pick Type C1 Disease

Start date: July 5, 2017
Phase: Early Phase 1
Study type: Interventional

This study is planned to study whether lithium carbonate has protective effect on the brain of Niemann-Pick disease type C1.

NCT ID: NCT02612129 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C

Arimoclomol Prospective Study in Participants Diagnosed With Niemann-Pick Disease Type C

Start date: June 14, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

A prospective, randomized, double-blind, placebo controlled therapeutic study in participants with confirmed diagnosis of Niemann-Pick disease type C (NPC). The purpose of this study is to assess the efficacy and safety of arimoclomol (compared to placebo) when it is administered as an add-on therapy to the participant's current prescribed best routine clinical care; participant's routine clinical care may, or may not, include miglustat. The CT-ORZY-NPC-002 study has been expanded to include an open label paediatric sub-study including participants aged 6 to <24 months at study enrolment.

NCT ID: NCT00005900 Active, not recruiting - Clinical trials for Mucopolysaccharidosis I

Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Start date: August 1999
Phase: N/A
Study type: Observational

OBJECTIVES: I. Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation (HSCT) for the presence of proinflammatory cytokines and for the production of nitric oxide by alveolar macrophages to identify possible risk factors for pulmonary complications. II. Investigate the underlying mechanism for the development of significant pulmonary complications in these patients during HSCT. III. Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-HSCT, or at 60 days post-HSCT if there has been no pulmonary complications.