A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 166

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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Related Trials

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

Phase 1

BTG International Ltd

Updated 8/21/2017