Adults 18 to 60, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12Primary· Month 12
A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan.
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
4
IFN Beta 1a 44 mcg TIW + Placebo
7
Percentage of Relapse-Free Subjects at Month 12 and Month 24Secondary· Month 12 and 24
Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.
Month 12
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
75.0
IFN Beta 1a 44 mcg TIW + Placebo
67.5
Month 24
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
60.0
IFN Beta 1a 44 mcg TIW + Placebo
50.0
Annualized Relapse Rate at Month 12 and 24Secondary· Month 12 and 24
Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Annualized relapse rate was calculated by dividing the total number of relapse events by the total number of days subjects participated in the study. This number was then multiplied by 365.25 to get an annualized rate.
Month 12
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
1.73
± 0.70
IFN Beta 1a 44 mcg TIW + Placebo
1.40
± 0.65
Month 24
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
1.05
± 0.73
IFN Beta 1a 44 mcg TIW + Placebo
1.14
± 0.82
Total Number of Reported Relapses at Month 3, 6, 12 and 24Secondary· Month 3, 6, 12 and 24
Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.
Month 3
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
1.00
± 0.00
IFN Beta 1a 44 mcg TIW + Placebo
1.00
± 0.00
Month 6
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
1.00
± 0.00
IFN Beta 1a 44 mcg TIW + Placebo
1.00
± NA
Month 12
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
1.50
± 0.58
IFN Beta 1a 44 mcg TIW + Placebo
1.00
± 0.00
Month 24
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
1.57
± 0.79
IFN Beta 1a 44 mcg TIW + Placebo
1.75
± 0.96
Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 MonthsSecondary· Baseline up to Month 24
Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Percentage of subjects treated with glucocorticoids due to relapses during 24 Months were reported here.
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
30.0
IFN Beta 1a 44 mcg TIW + Placebo
35.0
Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24Secondary· Month 12 and 24
Disability progression was assessed using EDSS. EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS) . Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as an increase of EDSS score of at least 1.0 point compared to baseline for subjects with an EDSS =\< 4.0. For subjects with an EDSS= 0 at baseline, EDSS progression was defined as an increase of EDSS score of at least 1.5 point. Percentage of subjects free from EDSS progression at Month 12 and 24 were reported
Month 12
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
92.5
IFN Beta 1a 44 mcg TIW + Placebo
82.5
Month 24
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
90.0
IFN Beta 1a 44 mcg TIW + Placebo
85.0
Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) ProgressionSecondary· Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months
EDSS progression is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). A sustained progression on EDSS score was defined as an EDSS progression confirmed into two consecutive assessment. EDSS values obtained during clinical attacks are not excluded for the assessment of EDSS progression. However, EDSS values obtained during MS attacks that are not confirmed after two consecutive assessments will be excluded from statistical analysis of confirmed EDSS progression. Hazard ratio for time t
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + [Curcumin (BCM95) and Placebo]
0.309
0.023 – 4.115
Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24Secondary· Month 24
A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan.
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
20.0
IFN Beta 1a 44 mcg TIW + Placebo
17.5
Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24Secondary· Month 12 and 24
CUA lesion was defined as new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.
Month 12
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
7.5
IFN Beta 1a 44 mcg TIW + Placebo
17.5
Month 24
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
15.0
IFN Beta 1a 44 mcg TIW + Placebo
12.5
Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24Secondary· Month 12 and 24
New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan.
Month 12
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
0.19
± 0.79
IFN Beta 1a 44 mcg TIW + Placebo
0.46
± 1.61
Month 24
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
0.21
± 0.63
IFN Beta 1a 44 mcg TIW + Placebo
0.13
± 0.63
Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24Secondary· Month 12 and 24
Mean number of new T1 (Hypointense) Lesions represents a measure of accumulation of inflammatory disease burden assessed on magnetic resonance imaging (MRI) scans.
Month 12
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
0.52
± 1.28
IFN Beta 1a 44 mcg TIW + Placebo
0.48
± 1.87
Month 24
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
0.19
± 0.68
IFN Beta 1a 44 mcg TIW + Placebo
0.04
± 0.21
Cumulative Number of New T1 (Hypointense) LesionsSecondary· Baseline up to Month 24
Cumulative number of new T1 (Hypointense) lesions were reported.
Group
Value
95% CI
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)
0.58
± 1.32
IFN Beta 1a 44 mcg TIW + Placebo
0.39
± 1.64
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Month 24.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal
· NA
· recruiting
NCT07524231 — Evaluation of the Effects of Laughter Yoga
· NA
· recruiting
NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS
· recruiting
NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity
· recruiting
NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck KGaA, Darmstadt, Germany
Last refreshed: 22 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01514370.