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

NCT01514370 | Completed Phase 2 Results

• 1 other identifier: EMR200136-549
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing; Interferon beta 1a; Curcumin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

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

  Month 12 and 24

• Annualized Relapse Rate at Month 12 and 24

  Month 12 and 24

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

  Month 3, 6, 12 and 24

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

  Baseline up to Month 24

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

  Month 12 and 24

Study Arms (2)

IFN beta 1a 44 mcg TIW + curcumin (BCM95)

EXPERIMENTAL

Drug: IFN beta 1a 44 mcg TIW; Drug: Curcumin

IFN beta 1a 44 mcg TIW + placebo

PLACEBO COMPARATOR

Drug: IFN beta 1a 44 mcg TIW; Drug: Placebo

Interventions

IFN beta 1a 44 mcg TIW DRUG

Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months.

Also known as: Interferon beta 1a

IFN beta 1a 44 mcg TIW + curcumin (BCM95); IFN beta 1a 44 mcg TIW + placebo

Curcumin DRUG

Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months.

Also known as: Rebif, BCM95

IFN beta 1a 44 mcg TIW + curcumin (BCM95)

Placebo DRUG

Subjects received placebo matched to curcumin orally twice a day for 24 months.

IFN beta 1a 44 mcg TIW + placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono S.P.A., Italy: collaborator

Study Sites (1)

Investigational Site

Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 34583214 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence

Interventions

Interferon beta-1a; Curcumin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono S.P.A., Italy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 23, 2012
• Study Start: April 30, 2012
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2016
• Last Updated: January 22, 2019
• Results First Posted: January 22, 2019

Record last verified: 2018-08

Locations

IT (1)