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

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ClinicalTrials.gov Identifier: NCT01514370
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
Merck Serono S.P.A., Italy
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: IFN beta 1a 44 mcg TIW
Drug: Curcumin
Drug: Placebo
Enrollment 80
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months. Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Period Title: Overall Study
Started 40 40
Safety Population 38 [1] 40 [1]
Completed 29 24
Not Completed 11 16
Reason Not Completed
Protocol Violation             2             3
Lost to Follow-up             0             2
Withdrawal by Subject             2             1
Adverse Event             1             3
Other             6             7
[1]
The Safety population consisted all randomized subjects who received at least 1 dose of study drug.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo Total
Hide Arm/Group Description Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months. Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) population included all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
36.5  (8.6) 34.3  (9.4) 35.4  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
28
  70.0%
22
  55.0%
50
  62.5%
Male
12
  30.0%
18
  45.0%
30
  37.5%
1.Primary Outcome
Title Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12
Hide Description 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.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.0%
7
  17.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFN Beta 1a 44 mcg TIW + Curcumin (BCM95), IFN Beta 1a 44 mcg TIW + Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Relapse-Free Subjects at Month 12 and Month 24
Hide Description 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.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Percentage of subjects
Month 12 75.0 67.5
Month 24 60.0 50.0
3.Secondary Outcome
Title Annualized Relapse Rate at Month 12 and 24
Hide Description 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.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: Relapse per year
Month 12 Number Analyzed 7 participants 11 participants
1.73  (0.70) 1.40  (0.65)
Month 24 Number Analyzed 12 participants 14 participants
1.05  (0.73) 1.14  (0.82)
4.Secondary Outcome
Title Total Number of Reported Relapses at Month 3, 6, 12 and 24
Hide Description 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.
Time Frame Month 3, 6, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: Relapses
Month 3 Number Analyzed 3 participants 5 participants
1.00  (0.00) 1.00  (0.00)
Month 6 Number Analyzed 3 participants 1 participants
1.00  (0.00) 1.00 [1]   (NA)
Month 12 Number Analyzed 4 participants 9 participants
1.50  (0.58) 1.00  (0.00)
Month 24 Number Analyzed 7 participants 4 participants
1.57  (0.79) 1.75  (0.96)
[1]
Standard Deviation could not be estimated as there was only 1 subject analyzed for this arm at the specified timepoint.
5.Secondary Outcome
Title Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months
Hide Description 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.
Time Frame Baseline up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Percentage of Subjects
30.0 35.0
6.Secondary Outcome
Title Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24
Hide Description 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
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Percentage of subjects
Month 12 92.5 82.5
Month 24 90.0 85.0
7.Secondary Outcome
Title Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression
Hide Description 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.
Time Frame Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.
Arm/Group Title IFN Beta 1a 44 mcg TIW + [Curcumin (BCM95) and Placebo]
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin or placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for 24 months.
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratio
0.309
(0.023 to 4.115)
8.Secondary Outcome
Title Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24
Hide Description 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.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Percentage of subjects
20.0 17.5
9.Secondary Outcome
Title Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24
Hide Description 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.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Percentage of Subjects
Month 12 7.5 17.5
Month 24 15.0 12.5
10.Secondary Outcome
Title Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24
Hide Description New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized subjects. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Lesions
Month 12 Number Analyzed 27 participants 26 participants
0.19  (0.79) 0.46  (1.61)
Month 24 Number Analyzed 28 participants 23 participants
0.21  (0.63) 0.13  (0.63)
11.Secondary Outcome
Title Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24
Hide Description Mean number of new T1 (Hypointense) Lesions represents a measure of accumulation of inflammatory disease burden assessed on magnetic resonance imaging (MRI) scans.
Time Frame Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized subjects. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Lesions
Month 12 Number Analyzed 27 participants 25 participants
0.52  (1.28) 0.48  (1.87)
Month 24 Number Analyzed 27 participants 23 participants
0.19  (0.68) 0.04  (0.21)
12.Secondary Outcome
Title Cumulative Number of New T1 (Hypointense) Lesions
Hide Description Cumulative number of new T1 (Hypointense) lesions were reported.
Time Frame Baseline up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: Lesions
0.58  (1.32) 0.39  (1.64)
13.Secondary Outcome
Title Median Change From Baseline in Whole Brain Volume at Month 12 and 24
Hide Description Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.
Time Frame Baseline, Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
As per change in Statistical Analysis Plan, data was not collected for this endpoint
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Median Change From Baseline in Regional Brain Volume at Month 12 and 24
Hide Description Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.
Time Frame Baseline, Month 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
As per change in Statistical Analysis Plan, data was not collected for this endpoint
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Flu-like Symptoms (FLS) Assessed by FLS Scale Score
Hide Description 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.
Time Frame Screening, Baseline, Month 3, 6, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Screening Number Analyzed 38 participants 40 participants
2.39  (2.48) 2.43  (2.34)
Baseline Number Analyzed 16 participants 13 participants
2.22  (2.76) 2.06  (2.21)
Month 3 Number Analyzed 27 participants 30 participants
1.91  (1.89) 1.89  (1.74)
Month 6 Number Analyzed 27 participants 25 participants
1.96  (1.83) 1.91  (2.42)
Month 12 Number Analyzed 23 participants 24 participants
1.45  (1.68) 1.36  (1.29)
Month 24 Number Analyzed 16 participants 11 participants
1.68  (1.71) 0.93  (0.92)
16.Secondary Outcome
Title Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation
Hide Description 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.
Time Frame Baseline up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who received at least one administration of study medication.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: Subjects
Subjects with TEAE 16 16
Subjects with TE-SAE 1 0
Subjects with TEAEs leading to discontinuation 1 3
Subjects with TEAEs leading to death 0 0
17.Secondary Outcome
Title Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters
Hide Description Laboratory assessment included haematology, chemistry, and urinalysis. Clinical significance was determined by the investigator.
Time Frame From screening up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who received at least one administration of study medication.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: Subjects
9 4
18.Secondary Outcome
Title Number of Subjects With One Concomitant Medication From Baseline up to Month 24
Hide Description Number of subjects with at least one concomitant medication from baseline up to month 24 were reported.
Time Frame Baseline up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Subjects
28 20
19.Secondary Outcome
Title Time on Treatment (Adherence to Treatment)
Hide Description Time up to which subjects were adhered to the treatment was reported.
Time Frame Baseline up to 2.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who received at least one administration of study medication.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 38 40
Median (Full Range)
Unit of Measure: Years
1.93
(0.3 to 2.1)
1.92
(0.1 to 2.2)
20.Secondary Outcome
Title Number of Subjects With Premature Termination From Treatment
Hide Description Number of subjects with premature termination from treatment were reported.
Time Frame Baseline up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Subjects
Adverse event 1 3
Consent withdrawn 2 1
Lost to follow up 0 2
Protocol Violation 2 3
Unspecified 6 7
21.Secondary Outcome
Title Hazard Ratio for Time to First Documented Relapse
Hide Description 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.
Time Frame Baseline up to Date at which first Relapse Occurs assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized subjects.
Arm/Group Title IFN Beta 1a 44 mcg TIW + [Curcumin (BCM95) and Placebo]
Hide Arm/Group Description:
Subjects received 500 milligram (mg) curcumin or placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for 24 months.
Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratio
0.808
(0.311 to 2.099)
Time Frame Baseline up to Month 24
Adverse Event Reporting Description Adverse events were assessed for the safety population. The Safety population included all randomized subjects who received at least 1 administration of study medication.
 
Arm/Group Title IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Hide Arm/Group Description Subjects received 500 milligram (mg) curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months. Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
All-Cause Mortality
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/38 (2.63%)   0/40 (0.00%) 
Infections and infestations     
Eye abscess * 1  1/38 (2.63%)  0/40 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) IFN Beta 1a 44 mcg TIW + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/38 (42.11%)   16/40 (40.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/38 (2.63%)  0/40 (0.00%) 
Ear and labyrinth disorders     
Ear pain * 1  1/38 (2.63%)  0/40 (0.00%) 
Vertigo * 1  1/38 (2.63%)  0/40 (0.00%) 
Endocrine disorders     
Autoimmune thyroiditis * 1  1/38 (2.63%)  0/40 (0.00%) 
Thyroiditis * 1  1/38 (2.63%)  0/40 (0.00%) 
Eye disorders     
Diplopia * 1  1/38 (2.63%)  0/40 (0.00%) 
Scotoma * 1  0/38 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  0/38 (0.00%)  2/40 (5.00%) 
Abdominal distension * 1  1/38 (2.63%)  0/40 (0.00%) 
Abdominal pain upper * 1  1/38 (2.63%)  2/40 (5.00%) 
Constipation * 1  1/38 (2.63%)  0/40 (0.00%) 
Diarrhoea * 1  0/38 (0.00%)  1/40 (2.50%) 
Nausea * 1  1/38 (2.63%)  0/40 (0.00%) 
Toothache * 1  1/38 (2.63%)  0/40 (0.00%) 
Dyspepsia * 1  1/38 (2.63%)  0/40 (0.00%) 
General disorders     
Chest pain * 1  1/38 (2.63%)  0/40 (0.00%) 
Cyst * 1  1/38 (2.63%)  0/40 (0.00%) 
Fatigue * 1  1/38 (2.63%)  0/40 (0.00%) 
Oedema peripheral * 1  0/38 (0.00%)  1/40 (2.50%) 
Infections and infestations     
Cystitis * 1  0/38 (0.00%)  1/40 (2.50%) 
Influenza * 1  0/38 (0.00%)  1/40 (2.50%) 
Injury, poisoning and procedural complications     
Venous injury * 1  1/38 (2.63%)  0/40 (0.00%) 
Investigations     
Gamma-glutamyltransferase increased * 1  0/38 (0.00%)  1/40 (2.50%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/38 (2.63%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/38 (2.63%)  0/40 (0.00%) 
Myalgia * 1  1/38 (2.63%)  0/40 (0.00%) 
Pain in extremity * 1  1/38 (2.63%)  1/40 (2.50%) 
Nervous system disorders     
Headache * 1  2/38 (5.26%)  1/40 (2.50%) 
Hypoaesthesia * 1  1/38 (2.63%)  0/40 (0.00%) 
Migraine * 1  1/38 (2.63%)  0/40 (0.00%) 
Multiple sclerosis relapse * 1  1/38 (2.63%)  0/40 (0.00%) 
Muscle spasticity * 1  0/38 (0.00%)  1/40 (2.50%) 
Paraesthesia * 1  1/38 (2.63%)  0/40 (0.00%) 
Trigeminal neuralgia * 1  0/38 (0.00%)  1/40 (2.50%) 
Psychiatric disorders     
Depression * 1  2/38 (5.26%)  2/40 (5.00%) 
Renal and urinary disorders     
Cystitis noninfective * 1  1/38 (2.63%)  0/40 (0.00%) 
Nephrolithiasis * 1  1/38 (2.63%)  0/40 (0.00%) 
Urinary incontinence * 1  1/38 (2.63%)  0/40 (0.00%) 
Urinary retention * 1  3/38 (7.89%)  0/40 (0.00%) 
Reproductive system and breast disorders     
Menstruation irregular * 1  1/38 (2.63%)  0/40 (0.00%) 
Oligomenorrhoea * 1  0/38 (0.00%)  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders     
Sleep apnoea syndrome * 1  1/38 (2.63%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  0/38 (0.00%)  1/40 (2.50%) 
Dermatitis atopic * 1  0/38 (0.00%)  1/40 (2.50%) 
Pruritus * 1  0/38 (0.00%)  1/40 (2.50%) 
Surgical and medical procedures     
Astringent therapy * 1  2/38 (5.26%)  0/40 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  1/38 (2.63%)  0/40 (0.00%) 
Hypertension * 1  1/38 (2.63%)  0/40 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01514370     History of Changes
Other Study ID Numbers: EMR200136-549
First Submitted: January 17, 2012
First Posted: January 23, 2012
Results First Submitted: October 25, 2017
Results First Posted: January 21, 2019
Last Update Posted: January 21, 2019