Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 184

Inclusion Criteria

Patients aged =18 with relapsing-remitting multiple sclerosis (EDSS score 0-5.5), with evidence of disease activity defined as at least one relapse or the presence of active MRI lesion/s consistent with MS during the year prior to inclusion
Patients who have refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 182
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

MS-related exclusion criteria:
• MS relapse or systemic corticosteroids in the previous 1 month
• Secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS)
• Treatment with other agents for MS within the previous 3 months (intertferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapherese) or within the previous 12 months (other MS drugs)
• Treatment with agents for the non-symptomatic treatment of MS within the previous 3 months

General exclusion criteria
• Pregnant or breast feeding
• Participation in a clinical study of an unlicensed drug in the previous 6 months
• Has a clinically significant abnormal serum biochemistry, haematology or urine examination values within 14 days prior to the start of the study.
• Has a 12-lead ECG with abnormal QTc interval within 14 days prior to the start of the study.
• Presence of pacemakers or foreign metal objects in the body which would contraindicate an MRI scan, or renal impairment which would contraindicate gadolinium injection
• Has any systemic disease, which can influence his/her safety and compliance, or the evaluation of disability.
• Any finding on medical history or physical examination which would prevent the patient being able to fully comply with the requirements of the study.
• Any finding on medical history or physical examination which would affect absorption of the study drug; e.g. metabolic disorders.
• Serious concomitant medical conditions: e.g. HIV infection, Hepatitis B or C, uncontrolled diabetes, malignancy.
• Current history of cancer, excluding localised non-melanoma skin cancer
• Known allergies to the study drug, its constituents or gadolinium (MRI contrast).
• Has suffered from major depression or any other psychiatric disorder
• Incapability of giving informed legal consent
• Co-worker, student, relative or spouse of the investigator
• Patients unable to swallow oral medications
• Previous participation in this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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