Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Serono S.P.A., Italy | INDUSTRY |
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.
The subjects must experience at least one Gadolinium (GD) enhancing Magnetic Resonance Imaging (MRI) lesion at the baseline visit or one Multiple Sclerosis (MS) relapse in the last 6 months before the screening visit.
Randomization, in a 1:1 ratio, will be done with two arms:
40 subjects with Interferon (IFN) beta 1 a 44 mcg TIW + Curcumin (BCM 95) and 40 subjects with IFN beta-1a 44 mcg TIW + placebo.
The study will last 42 months: 18 months of enrolment and 24 months of treatment period.
The study consists of 6 visits per subject: screening visit (Visit 0), baseline (Visit 1), a visit 3 months after baseline (Visit 2), 6 months after baseline (Visit 3), 12 months after baseline (Visit 4) and 24 months after baseline (Visit 5).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN beta 1a 44 mcg TIW + curcumin (BCM95) | Experimental |
| |
| IFN beta 1a 44 mcg TIW + placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IFN beta 1a 44 mcg TIW | Drug | Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at 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. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Relapse-Free Subjects at Month 12 and 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. | Month 12 and 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono S.P.A., Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34583214 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent-to-Treat (ITT) population included all randomized subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | IFN Beta 1a 44 mcg TIW + Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at 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. | ITT population included all randomized subjects. | Posted | Count of Participants | Participants | Month 12 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Curcumin | Drug | Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months. |
|
|
| Placebo | Drug | Subjects received placebo matched to curcumin orally twice a day for 24 months. |
|
| Annualized Relapse Rate at 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 and 24 |
| Total Number of Reported Relapses at 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, 6, 12 and 24 |
| Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months | 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. | Baseline up to Month 24 |
| Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at 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 and 24 |
| Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression | 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. | Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months |
| Percentage of Subjects With Active (New/Enlarging) T2 Lesions at 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. | Month 24 |
| Percentage of Subjects With Combined Unique Active (CUA) Lesions at 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 and 24 |
| Mean Number of New Gadolinium (Gd)-Enhancing Lesions at 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 and 24 |
| Mean Number of New T1 (Hypointense) Lesions at 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 and 24 |
| Cumulative Number of New T1 (Hypointense) Lesions | Cumulative number of new T1 (Hypointense) lesions were reported. | Baseline up to Month 24 |
| Median Change From Baseline in Whole Brain Volume at Month 12 and 24 | Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease. | Baseline, Month 12 and 24 |
| Median Change From Baseline in Regional Brain Volume at Month 12 and 24 | Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease. | Baseline, Month 12 and 24 |
| Flu-like Symptoms (FLS) Assessed by FLS Scale Score | 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. | Screening, Baseline, Month 3, 6, 12 and 24 |
| Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation | 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. | Baseline up to Month 24 |
| Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters | Laboratory assessment included haematology, chemistry, and urinalysis. Clinical significance was determined by the investigator. | From screening up to Month 24 |
| Number of Subjects With One Concomitant Medication From Baseline up to Month 24 | Number of subjects with at least one concomitant medication from baseline up to month 24 were reported. | Baseline up to Month 24 |
| Time on Treatment (Adherence to Treatment) | Time up to which subjects were adhered to the treatment was reported. | Baseline up to 2.2 years |
| Number of Subjects With Premature Termination From Treatment | Number of subjects with premature termination from treatment were reported. | Baseline up to Month 24 |
| Hazard Ratio for Time to First Documented Relapse | 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. | Baseline up to Date at which first Relapse Occurs assessed up to 24 months |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Other |
|
Subjects received placebo matched to curcumin orally twice a day along with IFN beta 1a 44 mcg subcutaneously TIW for approximately 24 months.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. |
|
|
|
| Secondary | Percentage of Relapse-Free Subjects at Month 12 and 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. | ITT population included all randomized subjects. | Posted | Number | Percentage of subjects | Month 12 and 24 |
|
|
|
| Secondary | Annualized Relapse Rate at 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. | 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. | Posted | Mean | Standard Deviation | Relapse per year | Month 12 and 24 |
|
|
|
| Secondary | Total Number of Reported Relapses at 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. | 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. | Posted | Mean | Standard Deviation | Relapses | Month 3, 6, 12 and 24 |
|
|
|
| Secondary | Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months | 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. | ITT population included all randomized subjects. | Posted | Number | Percentage of Subjects | Baseline up to Month 24 |
|
|
|
| Secondary | Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at 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 | ITT population included all randomized subjects. | Posted | Number | Percentage of subjects | Month 12 and 24 |
|
|
|
| Secondary | Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression | 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. | ITT population included all randomized subjects. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Ratio | Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months |
|
|
|
| Secondary | Percentage of Subjects With Active (New/Enlarging) T2 Lesions at 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. | ITT population included all randomized subjects. | Posted | Number | Percentage of subjects | Month 24 |
|
|
|
| Secondary | Percentage of Subjects With Combined Unique Active (CUA) Lesions at 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. | ITT population included all randomized subjects. | Posted | Number | Percentage of Subjects | Month 12 and 24 |
|
|
|
| Secondary | Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24 | New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan. | The ITT population included all randomized subjects. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint. | Posted | Mean | Standard Deviation | Lesions | Month 12 and 24 |
|
|
|
| Secondary | Mean Number of New T1 (Hypointense) Lesions at 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. | The ITT population included all randomized subjects. Here "Number analyzed" signifies those subjects who were evaluable for this outcome measure at the specified timepoint. | Posted | Mean | Standard Deviation | Lesions | Month 12 and 24 |
|
|
|
| Secondary | Cumulative Number of New T1 (Hypointense) Lesions | Cumulative number of new T1 (Hypointense) lesions were reported. | 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. | Posted | Mean | Standard Deviation | Lesions | Baseline up to Month 24 |
|
|
|
| Secondary | Median Change From Baseline in Whole Brain Volume at Month 12 and 24 | Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease. | As per change in Statistical Analysis Plan, data was not collected for this endpoint | Posted | Baseline, Month 12 and 24 |
|
|
| Secondary | Median Change From Baseline in Regional Brain Volume at Month 12 and 24 | Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease. | As per change in Statistical Analysis Plan, data was not collected for this endpoint | Posted | Baseline, Month 12 and 24 |
|
|
| Secondary | Flu-like Symptoms (FLS) Assessed by FLS Scale Score | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Screening, Baseline, Month 3, 6, 12 and 24 |
|
|
|
| Secondary | Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation | 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. | The Safety population included all subjects who received at least one administration of study medication. | Posted | Number | Subjects | Baseline up to Month 24 |
|
|
|
| Secondary | Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters | Laboratory assessment included haematology, chemistry, and urinalysis. Clinical significance was determined by the investigator. | The Safety population included all subjects who received at least one administration of study medication. | Posted | Number | Subjects | From screening up to Month 24 |
|
|
|
| Secondary | Number of Subjects With One Concomitant Medication From Baseline up to Month 24 | Number of subjects with at least one concomitant medication from baseline up to month 24 were reported. | The ITT population included all randomized subjects. | Posted | Number | Subjects | Baseline up to Month 24 |
|
|
|
| Secondary | Time on Treatment (Adherence to Treatment) | Time up to which subjects were adhered to the treatment was reported. | The Safety population included all subjects who received at least one administration of study medication. | Posted | Median | Full Range | Years | Baseline up to 2.2 years |
|
|
|
| Secondary | Number of Subjects With Premature Termination From Treatment | Number of subjects with premature termination from treatment were reported. | The Intent-to-Treat (ITT) population included all randomized subjects. | Posted | Number | Subjects | Baseline up to Month 24 |
|
|
|
| Secondary | Hazard Ratio for Time to First Documented Relapse | 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. | ITT population included all randomized subjects. | Posted | Number | 95% Confidence Interval | Ratio | Baseline up to Date at which first Relapse Occurs assessed up to 24 months |
|
|
|
| 1 |
| 38 |
| 16 |
| 38 |
| EG001 | 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. | 0 | 40 | 16 | 40 |
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Scotoma | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cyst | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Venous injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oligomenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Astringent therapy | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| Month 24 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Month 24 |
|
|
| Month 24 |
|
|
| Baseline |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 24 |
|
|
| Subjects with TEAEs leading to discontinuation |
|
| Subjects with TEAEs leading to death |
|
| Lost to follow up |
|
| Protocol Violation |
|
| Unspecified |
|