Dietary Supplement of Curcumin in Subjects With Active Relapsing Multi

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 Three Times a Week (TIW)

CompletedPhase 2Relapsing MSNCT01514370

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12 0.271

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Curcumin

Placebo

  • Placebo

Given to everyone in the trial

Results by group

Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12

Month 12

GroupValueIntervalNumber analysed
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)4 Participants40
IFN Beta 1a 44 mcg TIW + Placebo7 Participants40

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

4

IFN Beta 1a 44 mcg TIW + Placebo

7

p = 0.271

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
IFN Beta 1a 44 mcg TIW + Curcumin (BCM95)381 (2.6%)
IFN Beta 1a 44 mcg TIW + Placebo400 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12

    Month 12

    MRI lesions

Other measures (20)

  • Percentage of Relapse-Free Subjects at Month 12 and Month 24

    Month 12 and 24

    Relapses

  • Annualized Relapse Rate at Month 12 and 24

    Month 12 and 24

    Relapses

  • Total Number of Reported Relapses at Month 3, 6, 12 and 24

    Month 3, 6, 12 and 24

    Relapses

  • Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months

    Baseline up to Month 24

    Relapses

  • Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24

    Month 12 and 24

    Disability progression

  • 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

    Disability progressionRelapses

  • Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24

    Month 24

    MRI lesions

  • Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24

    Month 12 and 24

    MRI lesions

  • Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24

    Month 12 and 24

    MRI lesions

  • Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24

    Month 12 and 24

    MRI lesions

Who could take part

Relapsing MS · 18 to 60 · EDSS 0 to 5.5

Show the full criteria

Inclusion criteria

* Subjects with early diagnosis (no more than 3 years) of Relapsing Multiple Sclerosis according to the revised McDonald Criteria (2010) * Subjects currently in treatment with IFN beta-1a 44 mcg TIW, having received this treatment a minimum of 6 months and for not longer than 12 months before enrollment. * Subjects must experience at least one Gd-enhancing MRI lesion at baseline visit or one MS relapse in the last 6 months before screening visit. * Males and females between 18 - 60 years of age * Subjects with Expanded Disability Status Scale (EDSS) between 0-5.5 * No use of oral or systemic corticosteroids or corticotropin (ACTH) within 30 days prior to Screening visit. No use of any Disease Modifying Drug (DMD) (other than IFN beta-1a 44 mcg) 12 months prior to Screening visit * Be willing and able to comply with the protocol * Signed informed consent

Exclusion criteria

* Pregnancy and breast-feeding * History of alcohol or drug abuse * Serious psychiatric disorders * History or presence of serious or acute gastrointestinal disease such as gastric or duodenal ulcer, ulcerative colitis and inflammatory bowel or Crohn's disease * Subjects suffering by obstruction of the biliary tract * Any major medical condition that in the opinion of the Investigator could create a risk to the subject or could affect adherence with the trial protocol. * Subjects with inadequate haematological function (defined by leukocyte ≤ 2,0 x 10\^9 ; platelets ≤ 100 x 10\^9; haemoglobin ≤ 12 g/dl for female and ≤ 13 g/dl for male), liver function (defined by AST, ALT, alkaline phosphatase > 2.0 times upper limit of normal), thyroid function (In particular subjects with clinically overt hyperthyroidism or clinically overt hypothyroidism and in any case according to physician's discretion). * Known hypersensitivity to gadolinium * Any other condition that would prevent the subject from undergoing an MRI scan (impairment of Kidney function, metal prosthesis etc.) * Immunosuppressive therapy 12 months before screening visit * Use of some recognized drugs involved as enzyme substrates, inducers or inhibitors in P450 system * Use of antiplatelet agents or antihyperlipidemics * Any contra-indication according to IFN beta 1a 44 mcg Summary of Product Characteristics (SmPC)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Apr 2012

    2. Main results due

      Mar 2016

    3. Finished

      Mar 2016

    4. Results posted

      Jan 2019

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