Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01450124
• Date of registration: 18/09/2011
• Prospective Registration: No
• Primary sponsor: Universitätsklinikum Hamburg-Eppendorf
• Public title: Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) SABA
• Scientific title: Safety, Tolerability And Mechanism Of Action Of Boswellic Acids In Multiple Sclerosis and Clinically Isolated Syndrome: A MRI-Controlled, Multicenter, Baseline-To-Treatment, 32-Weeks, Open-Label, Phase IIa Trial
• Date of first enrolment: September 2011
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01450124
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Christoph Heesen, MD
• Affiliation: Universitätsklinikum Hamburg-Eppendorf

Key inclusion & exclusion criteria

Inclusion Criteria:

- Between the ages of 18 and 65 years, inclusive*

- Females and Males (as no specific gender-related differences are expected, no specific
gender distribution is planned. See GCP-V § 7 (2) Nr. 12)

- 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 (50)

- Diseases with similar clinical neurological symptoms (e.g. lues, borreliosis,
collagenosis or vasculitis) have been excluded by differential diagnostics

- EDSS score between 0.0 and 5.5, inclusive.

- Baseline MRI Lesion frequency of 0.5 or greater

- Patients are clinically stable, i.e. without relapse and not having received steroids
within 30 days prior to inclusion

- 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

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

If prior treatment was received, the subject must have been off treatment for the required
period prior to enrollment (see Table 2).

Table 2: Restrictions on pre-treatments Agent Glatiramer acetate (CopaxoneTM), Interferon
beta (BetaferonTM, AvonexTM, RebifTM) IV Ig, Azathioprine (ImurekTM), Methotrexate,
Cyclophosphamide (CytoxanTM), Mitoxantrone, plasma exchange, Cyclosporine, oral myelin,
Cladribine, natalizumab, and other immunosuppressive treatments Corticosteroids, ACTH Time
required off agent prior to enrollment 12 weeks 24 weeks 8 weeks Prior treatment with any
other investigational drug or procedure for MS will be evaluated individually by the
investigators.

- 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

- Known contraindications for MRI examinations including hypersensitivity to gadolinium,
severe renal insufficiency, a mechanical heart valve or any kind of metallic implants



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: Boswellic acids (BOSWELAN)

Primary Outcome(s)

Mean number of total Gd-enhancing lesions [Time Frame: 8 months]

Secondary Outcome(s)

Number of new active lesions (new Gd-enhancing lesions +new or enlarging non-enhancing T2 lesions) [Time Frame: 8 months]

Relapse rate [Time Frame: 8 months]

Secondary ID(s)

inims-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors