Boswellic Acids in Multiple Sclerosis

Phase 1

• Conditions: Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-014724-32-DE
• Lead Sponsor: niversity Medical Center Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-26
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified