Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Interferon beta 1a Curcumin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief 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).

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: IFN beta 1a 44 mcg TIW intervention 2: Curcumin intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months. intervention 2: Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months. intervention 3: Subjects received placebo matched to curcumin orally twice a day for 24 months.

Protocol document: