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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono S.P.A., Italy
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01514370
First received: January 17, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: IFN beta 1 a + curcumin (BCM 95)
Drug: IFN beta-1a + placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Difference between the proportion of subjects with active T2 lesions assessed by MRI in both examined arms at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of relapse-free subjects at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Proportion of relapse-free subjects at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Time to first documented relapse [ Time Frame: up to month 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects treated with glucocorticoids due to relapses [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Time to confirmed Expanded Disability Status Scale (EDSS) progression at 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Time to confirmed Expanded Disability Status Scale (EDSS) progression at 24 months [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects free from confirmed EDSS progression at 12 months [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Proportion of subjects free from confirmed EDSS progression at 24 months [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Mean number of Combined Unique Active (CUA) lesions per subject per MRI scan at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Mean number of Combined Unique Active (CUA) lesions per subject per MRI scan at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Mean number of new Gd-enhancing lesions per subject assessed by MRI at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Mean number of new Gd-enhancing lesions per subject assessed by MRI at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Frequency and severity of flu-like symptoms (FLS) as measured by FLS scale [ Time Frame: up to month 24 ] [ Designated as safety issue: Yes ]
    FLS may include headache, fatigue, fever, chills, myalgia, and arthralgia; typically, several of these symptoms occur concomitantly.


Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group 1
IFN beta 1 a 44 mcg TIW + curcumin (BCM 95)
Drug: IFN beta 1 a + curcumin (BCM 95)
IFN beta 1 a (44 mcg TIW) + curcumin (500 mg 2 times a day)
Other Names:
  • Interferon beta 1a
  • Rebif
  • curcumin
  • BCM95
Placebo Comparator: Treatment group 2
IFN beta-1a 44 mcg TIW + placebo
Drug: IFN beta-1a + placebo
IFN beta-1a 44 mcg TIW + placebo (1 tablet 2 times per day)
Other Names:
  • Interferon beta-1a
  • Rebif

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514370

Contacts
Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com

Locations
Italy
Investigational Site Recruiting
Naples, Italy, 80131
Sponsors and Collaborators
Merck KGaA
Merck Serono S.P.A., Italy
Investigators
Study Director: Medical Responsible Merck Serono S.P.A., Italy
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01514370     History of Changes
Other Study ID Numbers: EMR200136-549
Study First Received: January 17, 2012
Last Updated: January 31, 2014
Health Authority: Italy: The Italian Medicines Agency
Italy: Ethics Committee

Keywords provided by Merck KGaA:
Multiple Sclerosis
Relapsing
Interferon beta 1a
Curcumin

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Curcumin
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 01, 2014