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

Phase 2 Completed 80 enrolled Merck KGaA, Darmstadt, Germany Merck Serono S.P.A., Italy · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2012-04-30
Primary completion: 2016-03-31
Completion: 2016-03-31

Outcome

Missed primary endpoint

registry analysis (other test); IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) vs IFN Beta 1a 44 mcg TIW + Placebo; p = 0.271; Chi-squared NCT01514370 ↗

paper Although no between-group difference was present in terms of proportion of subjects free from new/enlarging T2 lesions PMID 34583214 ↗

Publications

Petracca M, Quarantelli M, Moccia M, Vacca G, Satelliti B, D'Ambrosio G, Carotenuto A, Ragucci M, Assogna F, Capacchione A, Lanzillo R, Morra VB. 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 TIW (CONTAIN): A randomized, controlled trial. Mult Scler Relat Disord. 2021 Nov;56:103274. doi: 10.1016/j.msard.2021.103274. Epub 2021 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Curcumin	Small molecule	500 mg	Oral
Background	IFN beta-1a	Protein / enzyme biologic	44 ug	Subcutaneous