- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450124
Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) (SABA)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- NeuroCure Clinical Research Center (NCRC)
-
Hamburg, Germany, 20246
- University Medical Centre Hamburg-Eppendorf
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of new active lesions (new Gd-enhancing lesions +new or enlarging non-enhancing T2 lesions)
Time Frame: 8 months
|
8 months
|
|
Relapse rate
Time Frame: 8 months
|
Annualized Relapse rate - comparing baseline to treatment
|
8 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christoph Heesen, MD, Universitätsklinikum Hamburg-Eppendorf
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Boswellic acid
Other Study ID Numbers
- inims-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsing Remitting Multiple Sclerosis
-
BiogenWithdrawnRelapsing-Remitting Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis
-
BiogenAbbVieTerminatedMultiple Sclerosis | Relapsing-Remitting Multiple SclerosisUnited States, Denmark, Italy, United Kingdom, Czechia, Canada, Hungary, Spain, Australia, Israel, Georgia, Serbia, Russian Federation, Ukraine, India, Poland, Brazil, France, Argentina, Germany, Greece, Ireland, Mexico, Moldova, Republic... and more
-
EMD SeronoPfizerCompletedRelapsing-remitting Multiple SclerosisUnited States, United Kingdom, Argentina, Austria, Brazil, France, Germany, Italy, Netherlands, Russian Federation, Spain, Switzerland
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)CompletedRelapsing-Remitting Multiple SclerosisUnited States
-
BiogenTerminatedRelapsing-Remitting Multiple SclerosisUnited States, Spain, Germany, Australia, Sweden, Czechia, France, Italy, United Kingdom
-
Novartis PharmaceuticalsWithdrawnMultiple Sclerosis (Relapsing Remitting)
-
Genzyme, a Sanofi CompanyTerminatedRelapsing-remitting Multiple SclerosisSweden, Poland, Russian Federation, United States, Canada
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple SclerosisGermany
-
Mitsubishi Tanabe Pharma CorporationCompletedRelapsing-remitting Multiple SclerosisCroatia, Bulgaria, Czech Republic, Italy, Russian Federation, Spain, United Kingdom, Germany, Lithuania, Poland, Belgium, Hungary, Serbia, Finland, Ukraine, Switzerland, Canada, Turkey
-
BiogenCompletedRelapsing-Remitting Multiple SclerosisUnited States
Clinical Trials on Boswellic acids (BOSWELAN)
-
Adel A.GomaaNot yet recruiting
-
Sultan Qaboos UniversityUnknown
-
Texas A&M UniversityRecruiting
-
University of TorontoCompletedHealthy | Increased Metabolic Requirement
-
University of Illinois at Urbana-ChampaignCompletedHypertrophyUnited States
-
University of British ColumbiaUnknown
-
Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedKwashiorkor | Marasmus | Protein-energy MalnutritionJamaica
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)Completed
-
Assistance Publique - Hôpitaux de ParisKyowa Hakko Kogyo (Japan) providing the amino acidsCompletedElderly | MetabolismFrance
-
S.LAB (SOLOWAYS)Center of New Medical Technologies; Triangel ScientificCompletedLDL Hyperlipoproteinemia | Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia | Triglyceride Storage Type I or II DiseaseRussian Federation