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

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ClinicalTrials.gov Identifier: NCT01450124
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE September 18, 2011
First Posted Date  ICMJE October 12, 2011
Last Update Posted Date February 25, 2020
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
Mean number of total Gd-enhancing lesions [ Time Frame: 8 months ]
Mean number of Gd-enhencing lesions comparing a baseline/pre-treatment interval of 3 months to a 3 months interval on treatment
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2011)
  • Mean number of total Gd-enhancing lesions [ Time Frame: 8 months ]
    Mean number of Gd-enhencing lesions comparing a baseline/pre-treatment interval of 3 months to a 3 months interval on treatment
  • Mean volume of total Gd-enhancing lesions [ Time Frame: 8 months ]
    Mean volume of Gd-enhencing lesions comparing a baseline/pre-treatment interval of 3 months to a 3 months interval on treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2011)
  • 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 ]
    Annualized Relapse rate - comparing baseline to treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)
Official Title  ICMJE 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
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.
Detailed Description Boswellic acids (BAs), the main biologically active compound of frankincense, are orally available and known to exhibit anti-inflammatory activities. This is a Phase IIa bicentric baseline-to-treatment study with the standardized frankincense extract Boswelan to test the safety, tolerability and efficacy of BAs in RR-MS patients. Following a 3-month screening phase, patients received an individualized dose finding identifying the highest well tolerated BOSWELAN dose for each patient. The primary outcome in the treatment phase (Stage 3) will first compare mean Gd-enhancing lesion number occurring during the 4 month baseline to mean Gd-enhancing lesion number occurring months 5, 6, 7, 8 on treatment in patients treated with a dose of at least 800 mg t.i.d.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Remitting Multiple Sclerosis
Intervention  ICMJE Drug: Boswellic acids (BOSWELAN)
8 months of treatment at a t.i.d. (Ter In Die (Latin: Three Times A Day) dose of between 400-1600 mg Boswelan
Other Name: BOSWELAN
Study Arms  ICMJE Experimental: Boswellic acids (BOSWELAN)
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.
Intervention: Drug: Boswellic acids (BOSWELAN)
Publications * Faizy TD, Broocks G, Thaler C, Rauch G, Gebert P, Stürner 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2015)
29
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2011)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01450124
Other Study ID Numbers  ICMJE inims-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christoph Heesen, MD Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP