E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Autoimmune Disease of the central nervous system |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 |
To determine the safety and tolerability of BOSWELAN in subjects with multiple sclerosis or clinically isolated syndrome |
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E.2.2 | Secondary objectives of the trial |
To describe the effect of Boswellic acids on the disease activity as assessed by monthly MRI measures |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Between the ages of 18 and 65 years, inclusive - Females and Males - Subjects with a clinically isolated syndrome (high risk of conversion to MS) as well as subjects with clinically definite relapsing-remitting according to published criteria - Subjects able of giving informed consent - Signed informed consent - EDSS score between 0.0 and 5.5, inclusive. - Patients have either failed standard treatment (interferon beta, glatiramer acetate) by clinical measures or were not eligible for any of the standard treatments available or opted not to start or to continue with any of these treatments -average of at least 0.5 Gd-enhancing lesions per month over the 4 month pre-treatment baseline period |
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E.4 | Principal exclusion criteria |
- ALT (SGPT) or AST (SGOT) > three times the upper limit of normal - Total white blood cell count < 3,000/mm3 - Platelet count < 85,000/mm3 - Creatinine > 1.5 mg/dl - Serology indicating active hepatitis B or C infection or other chronic liver disease - Positive pregnancy test, or breast-feeding female - Nausea/vomiting as a frequent complaint - History or signs of immunodeficiency - Concurrent, clinically significant (as determined by the investigator) cardiac, immunological, pulmonary, neurological, renal, and/or other major disease - History of alcohol or drug abuse within the 5 years prior to enrollment - Female subjects who are not post-menopausal or surgically sterile who are not using an highly effective method of birth control. Highly effective is defined as having a failure rate of <1%. Written documentation that the subject is post-menopausal or surgically sterile must be available prior to study start - Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule - Previous participation in this study - Participation in other pharmaceutical trials during this study or 3 months before - Patients hospitalized due to juridical or legal regulation -Known hypersensitivity to BA |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number and volume of total Gd-enhancing lesions |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Number of persisting Gd-enhancing lesions • Number of new active lesions (new Gd-enhancing lesions +new or enlarging non-enhancing T2 lesions) • Number of new Gd-enhancing lesions evolving into persistent hypointense lesions • T2 lesion volume • T1 hypointense lesion volume • Number of persisting T1 lesions • Brain atrophy (brain parenchymal fraction) • Magnetization Transfer Ratio (MTR) • Relapse rate
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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End of trial is Visit at month +8. A 4 months optional follow up will follow 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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |