NCT01514370

Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a

ProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, monocentric, double blind, placebo controlled, two arm study. Curcumin is derived from the rhizomes of the plant Curcuma longa (common name, turmeric) belonging to the Zingiberaceae family found in South Asian countries, especially India which is the largest producer. BCM95 (bioCurcumin) is a combination of a Curcumin extract and oil to enhance the bio-absorbability in humans. BCM95 may enhance and prolong the antioxidant and anti-inflammatory effects of the standard therapy maintaining a good safety profile.

Detailed description

The subjects must experience at least one Gadolinium (GD) enhancing Magnetic Resonance Imaging (MRI) lesion at the baseline visit or one Multiple Sclerosis (MS) relapse in the last 6 months before the screening visit. Randomization, in a 1:1 ratio, will be done with two arms: 40 subjects with Interferon (IFN) beta 1 a 44 mcg TIW + Curcumin (BCM 95) and 40 subjects with IFN beta-1a 44 mcg TIW + placebo. The study will last 42 months: 18 months of enrolment and 24 months of treatment period. The study consists of 6 visits per subject: screening visit (Visit 0), baseline (Visit 1), a visit 3 months after baseline (Visit 2), 6 months after baseline (Visit 3), 12 months after baseline (Visit 4) and 24 months after baseline (Visit 5).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	IFN beta 1a 44 mcg TIW	Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months.
DRUG	Curcumin	Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months.
DRUG	Placebo	Subjects received placebo matched to curcumin orally twice a day for 24 months.

Timeline

• Start date: 2012-04-30
• Primary completion: 2016-03-31
• Completion: 2016-03-31
• First posted: 2012-01-23
• Last updated: 2019-01-22
• Results posted: 2019-01-22

Locations

1 site across 1 country: Italy