Trial Outcomes & Findings for Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a (NCT NCT01514370)

Last Updated: 2019-01-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Month 12

Results posted on

2019-01-22

Participant Flow

Subjects who had been receiving treatment with subcutaneous interferon (IFN) beta 1a 44 microgram (mcg) three times a week (TIW) for a minimum of 6 months and for not longer than 24 months before enrollment, were enrolled in this study.

Participant milestones

Participant milestones
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Study STARTED	40	40
Overall Study Safety Population	38	40
Overall Study COMPLETED	29	24
Overall Study NOT COMPLETED	11	16

Reasons for withdrawal

Reasons for withdrawal
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Study Protocol Violation	2	3
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	1	3
Overall Study Other	6	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	Total n=80 Participants Total of all reporting groups
Age, Continuous	36.5 years STANDARD_DEVIATION 8.6 • n=5 Participants	34.3 years STANDARD_DEVIATION 9.4 • n=7 Participants	35.4 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: ITT population included all randomized subjects.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Month 12 and 24

Population: ITT population included all randomized subjects.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Percentage of Relapse-Free Subjects at Month 12 and Month 24 Month 24	60.0 Percentage of subjects	50.0 Percentage of subjects
Percentage of Relapse-Free Subjects at Month 12 and Month 24 Month 12	75.0 Percentage of subjects	67.5 Percentage of subjects

SECONDARY outcome

Timeframe: Month 12 and 24

Population: ITT population included all randomized subjects. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint.

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.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=12 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=14 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Annualized Relapse Rate at Month 12 and 24 Month 12	1.73 Relapse per year Standard Deviation 0.70	1.40 Relapse per year Standard Deviation 0.65
Annualized Relapse Rate at Month 12 and 24 Month 24	1.05 Relapse per year Standard Deviation 0.73	1.14 Relapse per year Standard Deviation 0.82

SECONDARY outcome

Timeframe: Month 3, 6, 12 and 24

Population: The ITT population included all randomized subjects. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=7 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=9 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Total Number of Reported Relapses at Month 3, 6, 12 and 24 Month 3	1.00 Relapses Standard Deviation 0.00	1.00 Relapses Standard Deviation 0.00
Total Number of Reported Relapses at Month 3, 6, 12 and 24 Month 6	1.00 Relapses Standard Deviation 0.00	1.00 Relapses Standard Deviation NA Standard Deviation could not be estimated as there was only 1 subject analyzed for this arm at the specified timepoint.
Total Number of Reported Relapses at Month 3, 6, 12 and 24 Month 12	1.50 Relapses Standard Deviation 0.58	1.00 Relapses Standard Deviation 0.00
Total Number of Reported Relapses at Month 3, 6, 12 and 24 Month 24	1.57 Relapses Standard Deviation 0.79	1.75 Relapses Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: ITT population included all randomized subjects.

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.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months	30.0 Percentage of Subjects	35.0 Percentage of Subjects

SECONDARY outcome

Timeframe: Month 12 and 24

Population: ITT population included all randomized subjects.

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

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24 Month 12	92.5 Percentage of subjects	82.5 Percentage of subjects
Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24 Month 24	90.0 Percentage of subjects	85.0 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months

Population: ITT population included all randomized subjects. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.

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 to first sustained EDSS progression was planned to be reported as per SAP.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=79 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression	0.309 Ratio Interval 0.023 to 4.115	—

SECONDARY outcome

Timeframe: Month 24

Population: ITT population included all randomized subjects.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24	20.0 Percentage of subjects	17.5 Percentage of subjects

SECONDARY outcome

Timeframe: Month 12 and 24

Population: ITT population included all randomized subjects.

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.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24 Month 12	7.5 Percentage of Subjects	17.5 Percentage of Subjects
Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24 Month 24	15.0 Percentage of Subjects	12.5 Percentage of Subjects

SECONDARY outcome

Timeframe: Month 12 and 24

Population: The ITT population included all randomized subjects. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint.

New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24 Month 12	0.19 Lesions Standard Deviation 0.79	0.46 Lesions Standard Deviation 1.61
Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24 Month 24	0.21 Lesions Standard Deviation 0.63	0.13 Lesions Standard Deviation 0.63

SECONDARY outcome

Timeframe: Month 12 and 24

Population: The ITT population included all randomized subjects. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint.

Mean number of new T1 (Hypointense) Lesions represents a measure of accumulation of inflammatory disease burden assessed on magnetic resonance imaging (MRI) scans.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24 Month 12	0.52 Lesions Standard Deviation 1.28	0.48 Lesions Standard Deviation 1.87
Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24 Month 24	0.19 Lesions Standard Deviation 0.68	0.04 Lesions Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: The Intent-to-Treat (ITT) population included all randomized subjects. Here "Number of subjects analyzed" included the subjects who were evaluable for this outcome measure.

Cumulative number of new T1 (Hypointense) lesions were reported.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=33 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=33 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Cumulative Number of New T1 (Hypointense) Lesions	0.58 Lesions Standard Deviation 1.32	0.39 Lesions Standard Deviation 1.64

SECONDARY outcome

Timeframe: Baseline, Month 12 and 24

Population: As per change in Statistical Analysis Plan, data was not collected for this endpoint

Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 12 and 24

Population: As per change in Statistical Analysis Plan, data was not collected for this endpoint

Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, Baseline, Month 3, 6, 12 and 24

Population: The Safety population included all subjects who received at least one administration of study medication. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint.

Flu-like symptoms were measured using FLS score in which subjects were scored as per the presence and intensity of muscle aches, chills, and weakness, each separately, on a scale of 0-3 as follows: 0 = absent; 1 = mild, do not interfere with daily activities; 2 = moderate, sufficient to interfere with daily activities; and 3 = severe, bed rest require. Body temperature also was also recorded to determine the presence of fever using the following scale: 0 (≤ 37.2 °C); 1 (≥ 37.3 °C but \< 37.8 °C); 2 (≥ 37.8 but \< 38.4 °C); and 3 (≥ 38.4 °C).The scores for each symptom (muscle aches, chills, weakness, body temperature) was added together to provide the combined flu-like symptom score ranging from 0 to 12 where 0 indicates absence of any symptom and 12 indicates the worst severity of the symptoms.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=38 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Flu-like Symptoms (FLS) Assessed by FLS Scale Score Month 24	1.68 Units on a scale Standard Deviation 1.71	0.93 Units on a scale Standard Deviation 0.92
Flu-like Symptoms (FLS) Assessed by FLS Scale Score Screening	2.39 Units on a scale Standard Deviation 2.48	2.43 Units on a scale Standard Deviation 2.34
Flu-like Symptoms (FLS) Assessed by FLS Scale Score Baseline	2.22 Units on a scale Standard Deviation 2.76	2.06 Units on a scale Standard Deviation 2.21
Flu-like Symptoms (FLS) Assessed by FLS Scale Score Month 3	1.91 Units on a scale Standard Deviation 1.89	1.89 Units on a scale Standard Deviation 1.74
Flu-like Symptoms (FLS) Assessed by FLS Scale Score Month 6	1.96 Units on a scale Standard Deviation 1.83	1.91 Units on a scale Standard Deviation 2.42
Flu-like Symptoms (FLS) Assessed by FLS Scale Score Month 12	1.45 Units on a scale Standard Deviation 1.68	1.36 Units on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: The Safety population included all subjects who received at least one administration of study medication.

AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 24 months. TEAEs include both Serious TEAEs and non-serious TEAEs.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=38 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation Subjects with TEAE	16 Subjects	16 Subjects
Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation Subjects with TE-SAE	1 Subjects	0 Subjects
Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation Subjects with TEAEs leading to discontinuation	1 Subjects	3 Subjects
Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation Subjects with TEAEs leading to death	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: From screening up to Month 24

Population: The Safety population included all subjects who received at least one administration of study medication.

Laboratory assessment included haematology, chemistry, and urinalysis. Clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=38 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters	9 Subjects	4 Subjects

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: The ITT population included all randomized subjects.

Number of subjects with at least one concomitant medication from baseline up to month 24 were reported.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Number of Subjects With One Concomitant Medication From Baseline up to Month 24	28 Subjects	20 Subjects

SECONDARY outcome

Timeframe: Baseline up to 2.2 years

Population: The Safety population included all subjects who received at least one administration of study medication.

Time up to which subjects were adhered to the treatment was reported.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=38 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Time on Treatment (Adherence to Treatment)	1.93 Years Full Range 0.49 • Interval 0.3 to 2.1	1.92 Years Full Range 0.60 • Interval 0.1 to 2.2

SECONDARY outcome

Timeframe: Baseline up to Month 24

Population: The Intent-to-Treat (ITT) population included all randomized subjects.

Number of subjects with premature termination from treatment were reported.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=40 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 Participants Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Number of Subjects With Premature Termination From Treatment Adverse event	1 Subjects	3 Subjects
Number of Subjects With Premature Termination From Treatment Consent withdrawn	2 Subjects	1 Subjects
Number of Subjects With Premature Termination From Treatment Lost to follow up	0 Subjects	2 Subjects
Number of Subjects With Premature Termination From Treatment Protocol Violation	2 Subjects	3 Subjects
Number of Subjects With Premature Termination From Treatment Unspecified	6 Subjects	7 Subjects

SECONDARY outcome

Timeframe: Baseline up to Date at which first Relapse Occurs assessed up to 24 months

Population: ITT population included all randomized subjects.

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. Hazard ratio for time to first documented relapse was planned to be reported as per SAP.

Outcome measures

Outcome measures
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=80 Participants Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Hazard Ratio for Time to First Documented Relapse	0.808 Ratio Interval 0.311 to 2.099	—

Adverse Events

IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

IFN Beta 1a 44 mcg TIW + Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) n=38 participants at risk Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.	IFN Beta 1a 44 mcg TIW + Placebo n=40 participants at risk Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Infections and infestations Eye abscess	2.6% 1/38 • Baseline up to Month 24 Adverse events were assessed for the safety population. The Safety population included all randomized subjects who received at least 1 administration of study medication.	0.00% 0/40 • Baseline up to Month 24 Adverse events were assessed for the safety population. The Safety population included all randomized subjects who received at least 1 administration of study medication.

Other adverse events

Additional Information

Merck KGaA Communication Center

Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60