CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
IFN beta 1a 44 mcg TIW +2 moredrug
Likely dose
IFN beta 1a 44 mcg TIWfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01514370
NCT01514370Phase 2Completed

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)

Merck KGaA, Darmstadt, Germany·interventional·Posted Jan 23, 2012·Updated Jan 22, 2019

In Brief

A Phase 2 clinical trial evaluating IFN beta 1a 44 mcg TIW, Curcumin, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2012
Enrollment StartApr 30, 2012
Primary CompletionMar 31, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.4 years ago

Interventions

IFN beta 1a 44 mcg TIWdrug

Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months.

Curcumindrug

Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months.

Placebodrug

Subjects received placebo matched to curcumin orally twice a day for 24 months.