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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR MIGLUSTAT

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Clinical Trials for Miglustat

Trial ID Title Status Sponsor Phase Summary
NCT00194649 Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study (MIG 2) Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 4 The purpose of this research study is to help in the development of safe, effective and reversible male contraception. We are examining the impact of the drug Miglustat on sperm production in normal men. We want to see if Miglustat will inhibit sperm production in men and act as a reversible male contraceptive, as a study in mice administered Miglustat showed a reversible inhibition of sperm production. We believe Miglustat may have some potential as a safe, reversible male contraceptive.
NCT00194649 Glycosphingolipid Inhibition and Spermatogenesis in Man: A Pilot Study (MIG 2) Completed University of Washington Phase 4 The purpose of this research study is to help in the development of safe, effective and reversible male contraception. We are examining the impact of the drug Miglustat on sperm production in normal men. We want to see if Miglustat will inhibit sperm production in men and act as a reversible male contraceptive, as a study in mice administered Miglustat showed a reversible inhibition of sperm production. We believe Miglustat may have some potential as a safe, reversible male contraceptive.
NCT00319046 Oral Miglustat in Adult Patients With Stable Type 1 Gaucher Disease Completed Actelion Phase 3 Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy, safety and tolerability of miglustat in maintaining diseases stability after a switch from ERT.
NCT00418847 Pharmacokinetics and Tolerability of Zavesca® (Miglustat) In Patients With Juvenile GM2 Gangliosidosis Completed Actelion Phase 2 The purpose of the study is to investigate the pharmacokinetics of Zavesca (miglustat, OGT918) when given as single and multiple doses in juvenile patients with GM2 gangliosidosis.
NCT00418847 Pharmacokinetics and Tolerability of Zavesca® (Miglustat) In Patients With Juvenile GM2 Gangliosidosis Completed The Hospital for Sick Children Phase 2 The purpose of the study is to investigate the pharmacokinetics of Zavesca (miglustat, OGT918) when given as single and multiple doses in juvenile patients with GM2 gangliosidosis.
NCT00517153 Miglustat in Niemann-Pick Type C Disease Completed Actelion Phase 2 This is a phase II randomized controlled study of miglustat in adult and juvenile patients with Niemann-Pick Type C disease. Up to 42 patients will be randomised in a 2:1 ratio to either treatment with miglustat or to a non-treatment group. Both groups will follow an identical visit schedule.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Miglustat

Condition Name

Condition Name for Miglustat
Intervention Trials
Cystic Fibrosis 4
Pompe Disease 3
GM2 Gangliosidoses 2
Niemann-Pick Disease, Type C 2
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Condition MeSH

Condition MeSH for Miglustat
Intervention Trials
Niemann-Pick Diseases 5
Niemann-Pick Disease, Type C 5
Niemann-Pick Disease, Type A 5
Fibrosis 4
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Clinical Trial Locations for Miglustat

Trials by Country

Trials by Country for Miglustat
Location Trials
United States 26
France 3
Taiwan 3
Spain 3
Canada 3
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Trials by US State

Trials by US State for Miglustat
Location Trials
California 4
Florida 3
Pennsylvania 2
Minnesota 2
New York 2
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Clinical Trial Progress for Miglustat

Clinical Trial Phase

Clinical Trial Phase for Miglustat
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Miglustat
Clinical Trial Phase Trials
Completed 10
Recruiting 7
Not yet recruiting 2
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Clinical Trial Sponsors for Miglustat

Sponsor Name

Sponsor Name for Miglustat
Sponsor Trials
Actelion 9
Amicus Therapeutics 3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
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Sponsor Type

Sponsor Type for Miglustat
Sponsor Trials
Other 15
Industry 14
NIH 6
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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Farmers Insurance
QuintilesIMS
Queensland Health
Citi
Accenture
Johnson and Johnson
Cipla
Express Scripts

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