OPTIMUM LT non-comparative extension study of ponesimod 20mg in RMS
Research type
Research Study
Full title
Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis
IRAS ID
219678
Contact name
Agnès Demazières
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd.
Eudract number
2016-004719-10
Duration of Study in the UK
6 years, 5 months, 0 days
Research summary
This is a study to find out whether paticipants with relapsing forms of multiple sclerosis (RMS) can tolerate and benefit from ponesimod treatment over a long period of time (maximum of 240 weeks or approximately 4 1/2 years).
Multiple Sclerois (MS) affects an estimated 202.5 million people worldwide, of whom approximately 630,000 are in Europe and 250,000 to 350,000 in the United States.
The incidence of MS is about 7 cases per 100,000 persons per year. The prevalence rate varies between races and geographical latitudes, ranging from 50 to 120 per 100,000. MS is the most common chronic neurologic disease in adults between 20 and 50 years of age with a peak onset of MS in the early thirties. Women are affected approximately twice as often as men. In 2 to 5% of patients, disease presents before the age of 16.
Ponesimod (study drug) is the only drug that will be tested in this research study. Everyone participating in the study will take ponesimod.
Ponesimod is a new oral drug that stops certain white blood cells called lymphocytes, from damaging the central nervous system.
The treatment is planned to last for approximately 4 1/2 years but the study may stop earlier, for example if ponesimod becomes available for prescription in the UK.
The daily dose of ponesimod will be slowly increased from 2 mg to 10 mg during the first 14 days of treatment (up-titration period). From Day 15 until the end of treatment, the participant will take 20 mg of ponesimod per day (maintenance period).REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0373
Date of REC Opinion
4 Jan 2018
REC opinion
Further Information Favourable Opinion