Clinical Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Miglustat in Patients With Stable Type 1 Gaucher Disease

Exclusion Criteria

• •1. History or evidence of oculomotor gaze palsy, ataxia or other clinical manifestations typically associated with neuronopathic type 3 Gaucher disease.
• •2. Not ambulant patients, or with progressive symptomatic documented bone disease.
• •3. Splenectomy before 18 years of age for splenomegaly and/or thrombocytopenia.
• •4. Peripheral polyneuropathy (not mononeuropathy) documented with both clinical signs and symptoms, and electrodiagnostic (EDX).
• •5. Patients (males and females) who do not agree to use reliable contraception throughout the study and for 3 months after cessation of miglustat treatment.
• •6. Female patients who are pregnant or breast feeding, or without pregnancy test prior to Day 1.
• •7. History of significant lactose intolerance.
• •8. Clinically significant diarrhea (\>3 liquid stools per day for \>7 days) without definable cause within 6 months prior to Day 1, or a history of clinically relevant gastrointestinal disorders.
• •9. History of cataracts or known increased risk of cataract formation.
• •10. Severe renal impairment i.e., with a creatinine clearance \<30 ml/min/1.73m\^2
• •11. Concomitant active medical condition such as human immunodeficiency virus (HIV) or hepatitis B/C that would render patients unsuitable for study.
• •12. Previous treatment with miglustat.