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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01450124
First received: September 18, 2011
Last updated: January 22, 2014
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Boswellic acids (BOSWELAN)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (MS)aAnd Clinically Isolated Syndrome (CIS): A MRI-Controlled, Multicenter, Baseline-To-Treatment, 32-Weeks, Open-Label, Phase IIa Trial In Patients With Relapsing-Remitting Multiple Sclerosis Or Clinically Isolated Syndrome

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Mean number of total Gd-enhancing lesions [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean volume of Gd-enhencing lesions comparing a baseline/pre-treatment interval of 3 months to a 3 months interval on treatment


Secondary Outcome Measures:
  • Number of new active lesions (new Gd-enhancing lesions +new or enlarging non-enhancing T2 lesions) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Annualized Relapse rate - comparing baseline to treatment


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Baseline to treatment single arm
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450124

Locations
Germany
NeuroCure Clinical Research Center (NCRC)
Berlin, Germany, 10117
University Medical Centre Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Christoph Heesen, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01450124     History of Changes
Other Study ID Numbers: inims-03
Study First Received: September 18, 2011
Last Updated: January 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Boswellic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014