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

NCT01450124 | Completed Phase 2 DMC

• 1 other identifier: inims-03
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the safety and tolerability of BOSWELAN in subjects with multiple sclerosis or clinically isolated syndrome and to describe the effect of Boswellic acids on the disease activity as assessed by monthly MRI measures.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Mean number of total Gd-enhancing lesions

  Mean number of Gd-enhencing lesions comparing a baseline/pre-treatment interval of 3 months to a 3 months interval on treatment

  8 months

Secondary Outcomes (2)

• Number of new active lesions (new Gd-enhancing lesions +new or enlarging non-enhancing T2 lesions)

  8 months

• Relapse rate

  8 months

Study Arms (1)

Boswellic acids (BOSWELAN)

EXPERIMENTAL

Baseline to treatment single arm - 4 months baseline and 8 months of treatment at a t.i.d. (Ter In Die (Latin: Three Times A Day) dose of between 400-1600 mg of BOSWELAN.

Drug: Boswellic acids (BOSWELAN)

Interventions

Boswellic acids (BOSWELAN) DRUG

8 months of treatment at a t.i.d. (Ter In Die (Latin: Three Times A Day) dose of between 400-1600 mg Boswelan

Also known as: BOSWELAN

Boswellic acids (BOSWELAN)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (2)

NeuroCure Clinical Research Center (NCRC)

Berlin, 10117, Germany

Location

University Medical Centre Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• Faizy TD, Broocks G, Thaler C, Rauch G, Gebert P, Sturner KH, Flottmann F, Leischner H, Kniep HC, Stellmann JP, Heesen C, Fiehler J, Gellissen S, Hanning U. Development of Cortical Lesion Volumes on Double Inversion Recovery MRI in Patients With Relapse-Onset Multiple Sclerosis. Front Neurol. 2019 Feb 22;10:133. doi: 10.3389/fneur.2019.00133. eCollection 2019.

  PMID: 30873106 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christoph Heesen, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2011
• First Posted: October 12, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

DE (2)