relapsing-remitting multiple sclerosis MedDRA version: 14.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: BCG20-0134
Product Code: BCG20-0134
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BGC20-0134
Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate
Sponsors
BTG International Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: General Aim: To assess the efficacy and safety of BGC20-0134 in patients with RRMS treated for 24 weeks in the double-blind period and for a further 24 weeks in the open-label period Primary Endpoint: Cumulative number of new gadolinium-enhanced (GdE) T1 weighted lesions developing while on treatment (specifically the sum of new GdE T1 lesions seen on MRI at weeks 12, 16, 20 and 24) ;Secondary Objective: • MRI endpoints: Cumulative number of total GdE T1 weighted lesions Cumulative number of new T2 weighted lesions Patients free of GdE (T1-weighted) lesions Change in volume of GdE T1 weighted, and new T2-weighted lesions Brain atrophy Cumulative number of new T1 hypointense lesions (black holes) • Disease burden, T1 and T2 lesion activity at week 48 • Number of clinical relapses from baseline • Change on the Expanded Disability Status Scale (EDSS) • Number of patients receiving methylprednisolone treatment for a relapse • Serum levels of cytokines during the first 24 weeks • Quality of life (MSQOL-54) assessment • PK for determination of circulating levels of BGC20-0134 and plasma concentrations of DHGLA during the first 24 weeks. • Safety assessment All secondary variables will be analysed in the double-blind period, however, all variables with the exception of some of the week 24 specific MRI variables will be analysed in the open-label phase.;Primary end point(s): Cumulative number of new gadolinium-enhanced (GdE) T1 weighted lesions developing while on treatment (specifically the sum of new GdE T1 lesions seen on MRI at weeks 12, 16, 20 and 24).;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): see E.2.2 Secondary objectives ;Timepoint(s) of evaluation of this end point: All secondary variables will be analysed in the double-blind period, however, all variables with the exception of some of the week 24 specific MRI variables will be analysed in the open-label phase. | — |
Countries
Belgium, European Union, France, Germany, Russian Federation, Spain
Contacts
Public ContactFayaz Master
BTG International Ltd
Outcome results
None listed