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Relapsing Remitting Multiple SclerosisPhase 2SABANCT01450124

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

A Phase 2 study testing Boswellic acids (BOSWELAN) in people with Relapsing Remitting Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Relapsing Remitting Multiple Sclerosis
What is being tested?
Boswellic acids (BOSWELAN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesGermany
Study dates
Sep 2011to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • NeuroCure Clinical Research Center (NCRC)

    Berlin, 10117

  • University Medical Centre Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

Official 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

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.

Read the 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.

Being tested
Boswellic acids (BOSWELAN)
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boswellic acids (BOSWELAN)Drug

    Also called 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

Study groups in NCT01450124
Study groupRoleWhat they receive
Boswellic acids (BOSWELAN)ExperimentalBaseline 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.
Receives: Drug: Boswellic acids (BOSWELAN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 months

Secondary outcomes (2)

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

    Measured: 8 months

  2. Relapse rate

    Annualized Relapse rate - comparing baseline to treatment

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01450124
Sponsor's protocol ID
inims-03
Acronym
SABA
Status last verified
Feb 2020
First submitted
18 Sep 2011
Last updated
25 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30873106

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Boswellic acids (BOSWELAN) in people with Relapsing Remitting Multiple Sclerosis, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean number of total Gd-enhancing lesions (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01450124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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