Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome
Conditions
Interventions
Product Name: BOSWELAN
Product Code: BOSWELAN
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: BOSWELAN
Current Sponsor code: BOS
Sponsors
University Medical Center Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - ALT (SGPT) or AST (SGOT) > three times the upper limit of normal - Total white blood cell count 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of BOSWELAN in subjects with multiple sclerosis or clinically isolated syndrome ;Secondary Objective: To describe the effect of Boswellic acids on the disease activity as assessed by monthly MRI measures;Primary end point(s): Number and volume of total Gd-enhancing lesions;Timepoint(s) of evaluation of this end point: month 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: month 8, month 12; 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 | — |
Countries
Germany
Contacts
Public ContactMS Outpatient Unit
Institute for Neuroimmunology and Clinical Multiple Sclerosis (MS) Research, University Medical Center Eppendorf
Outcome results
None listed