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Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod

Multiple Sclerosis Clinical Trial

Official title:
Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod

Clinical Trial Summary

To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.

Clinical Trial Description

PURPOSE: To investigate whether polymorphic differences can be identified between Multiple sclerosis (MS) patients treated by fingolimod who had liver enzymes elevation compared to those who do not. OBJECTIVE: To determine whether elevated liver enzyme tests (ALT, AST, GGT or bilirubinemia above the upper limit of normal) in MS patients treated with fingolimod is associated with genetic polymorphisms. METHOD OF RECRUITMENT: Patients will be identified through a clinic database and chart reviews. A phone call will be made to determine interest. Upon a follow-up neurological consultation, consent into study will be sought. PROCEDURES: Blood samples will be collected for genetic analyses, fingolimod and fingolimod-phosphate quantification and a questionnaire will be administered ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05516303
Study type Observational
Source University Hospital, Caen
Contact Sophie Nguyen, MSc
Phone +33(0)231065127
Email nguyen-s@chu-caen.fr
Status Recruiting
Phase
Start date June 7, 2022
Completion date October 31, 2022
View Details
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