Trial · NCT01514370
Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a
NCT01514370, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2019-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a. Trials, record NCT01514370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01514370
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a
- NCT number
- NCT01514370
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Multiple Sclerosis
- Interventions
- IFN beta 1a 44 mcg TIW, Curcumin, Placebo
- First posted
- 2012-01-23
- Last updated
- 2019-01-22
- Results first posted
- 2019-01-22
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12 | 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. |
| Secondary | Percentage of Relapse-Free Subjects at Month 12 and Month 24 | 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. |
| Secondary | Annualized Relapse Rate at Month 12 and 24 | 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. |
| Secondary | Total Number of Reported Relapses at Month 3, 6, 12 and 24 | 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. |
| Secondary | Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months | Baseline up to Month 24 | Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Percentage of subjects treated with glucocorticoids due to relapses during 24 Months were reported here. |
| Secondary | Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24 | 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 |
| Secondary | Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression | Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months | EDSS progression is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). A sustained progression on EDSS score was defined as an EDSS progression confirmed into two consecutive assessment. EDSS values obtained during clinical attacks are not excluded for the assessment of EDSS progression. However, EDSS values obtained during MS attacks that are not confirmed after two consecutive assessments will be excluded from statistical analysis of confirmed EDSS progression. Hazard ratio for time to first sustained EDSS progression was planned to be reported as per SAP. |
| Secondary | Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24 | 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. |
| Secondary | Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24 | 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. |
| Secondary | Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24 | Month 12 and 24 | New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12 | Month 12 | ITT population included all randomized subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Relapse-Free Subjects at Month 12 and Month 24 | Month 12 and 24 | ITT population included all randomized subjects. | Percentage of subjects | NUMBER |
| SECONDARY | Annualized Relapse Rate at Month 12 and 24 | Month 12 and 24 | 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 per year | MEAN |
| SECONDARY | Total Number of Reported Relapses at Month 3, 6, 12 and 24 | Month 3, 6, 12 and 24 | 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. | Relapses | MEAN |
| SECONDARY | Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months | Baseline up to Month 24 | ITT population included all randomized subjects. | Percentage of Subjects | NUMBER |
| SECONDARY | Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24 | Month 12 and 24 | ITT population included all randomized subjects. | Percentage of subjects | NUMBER |
| SECONDARY | Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression | Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months | ITT population included all randomized subjects. Here, Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure. | Ratio | NUMBER |
| SECONDARY | Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24 | Month 24 | ITT population included all randomized subjects. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24 | Month 12 and 24 | ITT population included all randomized subjects. | Percentage of Subjects | NUMBER |
| SECONDARY | Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24 | Month 12 and 24 | The ITT population included all randomized subjects. Here Number analyzed signifies those subjects who were evaluable for this outcome measure at the specified timepoint. | Lesions | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12 | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 4 | Participants | ||
| Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12 | IFN Beta 1a 44 mcg TIW + Placebo | 7 | Participants | ||
| Percentage of Relapse-Free Subjects at Month 12 and Month 24 | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | Month 12 | 75.0 | Percentage of subjects | |
| Percentage of Relapse-Free Subjects at Month 12 and Month 24 | IFN Beta 1a 44 mcg TIW + Placebo | Month 12 | 67.5 | Percentage of subjects | |
| Percentage of Relapse-Free Subjects at Month 12 and Month 24 | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | Month 24 | 60.0 | Percentage of subjects | |
| Percentage of Relapse-Free Subjects at Month 12 and Month 24 | IFN Beta 1a 44 mcg TIW + Placebo | Month 24 | 50.0 | Percentage of subjects | |
| Annualized Relapse Rate at Month 12 and 24 | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | Month 12 | 1.73 | Standard Deviation 0.70 | Relapse per year |
| Annualized Relapse Rate at Month 12 and 24 | IFN Beta 1a 44 mcg TIW + Placebo | Month 12 | 1.40 | Standard Deviation 0.65 | Relapse per year |
| Annualized Relapse Rate at Month 12 and 24 | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | Month 24 | 1.05 | Standard Deviation 0.73 | Relapse per year |
| Annualized Relapse Rate at Month 12 and 24 | IFN Beta 1a 44 mcg TIW + Placebo | Month 24 | 1.14 | Standard Deviation 0.82 | Relapse per year |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 40 | |
| Overall Study | STARTED | IFN Beta 1a 44 mcg TIW + Placebo | 40 | |
| Overall Study | Safety Population | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 38 | |
| Overall Study | Safety Population | IFN Beta 1a 44 mcg TIW + Placebo | 40 | |
| Overall Study | COMPLETED | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 29 | |
| Overall Study | COMPLETED | IFN Beta 1a 44 mcg TIW + Placebo | 24 | |
| Overall Study | NOT COMPLETED | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 11 | |
| Overall Study | NOT COMPLETED | IFN Beta 1a 44 mcg TIW + Placebo | 16 |
Source ClinicalTrials.gov
Adverse events98
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 1 | 38 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | IFN Beta 1a 44 mcg TIW + Placebo | 0 | 40 | |
| other | Ear pain | Ear and labyrinth disorders | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 1 | 38 | |
| other | Ear pain | Ear and labyrinth disorders | IFN Beta 1a 44 mcg TIW + Placebo | 0 | 40 | |
| other | Vertigo | Ear and labyrinth disorders | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 1 | 38 | |
| other | Vertigo | Ear and labyrinth disorders | IFN Beta 1a 44 mcg TIW + Placebo | 0 | 40 | |
| other | Autoimmune thyroiditis | Endocrine disorders | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 1 | 38 | |
| other | Autoimmune thyroiditis | Endocrine disorders | IFN Beta 1a 44 mcg TIW + Placebo | 0 | 40 | |
| other | Thyroiditis | Endocrine disorders | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 1 | 38 | |
| other | Thyroiditis | Endocrine disorders | IFN Beta 1a 44 mcg TIW + Placebo | 0 | 40 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | ||
| Total, all-cause mortality | IFN Beta 1a 44 mcg TIW + Placebo | ||
| Total, other adverse events | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 16 | 38 |
| Total, other adverse events | IFN Beta 1a 44 mcg TIW + Placebo | 16 | 40 |
| Total, serious adverse events | IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) | 1 | 38 |
| Total, serious adverse events | IFN Beta 1a 44 mcg TIW + Placebo | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34583214 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) vs IFN Beta 1a 44 mcg TIW + Placebo: Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12 | Trial comparisons |
| IFN Beta 1a 44 mcg TIW + Curcumin (BCM95) vs IFN Beta 1a 44 mcg TIW + Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01514370
GET https://conductscience.org/api/trials/v1/NCT01514370/registered?page=2