NCT01450124

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-10-12
• Last updated: 2020-02-25

Locations

2 sites across 1 country: Germany