E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
relapsing-remitting multiple sclerosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
General Aim: To assess the efficacy and safety of BGC20-0134 in patients with RRMS treated for 24 weeks in 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)
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E.2.2 | Secondary objectives of the trial |
• 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) • Number of clinical relapses from baseline • Appearance of a new symptom or worsening of an old symptom, attributable to MS • 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 dihomo-gamma linolenic acid (DHGLA) during the first 24 weeks. • Safety assessment During the open label period only the clinical endpoints are assessed. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |