Homocystinuria: Treatment With N-Acetylcysteine

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine if oral N-acetylcysteine is effective in lowering homocysteine in individuals with homocystinuria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: March of Dimes
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Homocystinuria (lens dislocation and hyperhomocysteinemia)

• Age ≥ 18 (the age of majority in Canada)

Exclusion Criteria:

• Nursing mothers or pregnant women

• Chronic liver disease

• Taking nitrates

• Cystine stone formers

• History of active peptic ulcer disease

• Subjects receiving carbamazepine and metoclopramide

• Use of other products containing cysteine or N-acetylcysteine (e.g. nebulized NAC, cysteine supplements, methionine restriction)

• Hypersensitivity to any ingredient in the study product

• Clinically significant, abnormal laboratory test on screening (Visit 2)

Other Criteria:

• Women of child-bearing capacity must be using an acceptable method of birth control and have a negative pregnancy test before being enrolled