Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a
Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: IFN beta 1 a + curcumin (BCM 95) (Drug); IFN beta-1a + placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s): Medical Responsible, Study Director, Affiliation: Merck Serono S.P.A., Italy
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.
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Difference between the proportion of subjects with active T2 lesions assessed by MRI in both examined arms at Month 12
Secondary outcome: Proportion of relapse-free subjects at Month 12Proportion of relapse-free subjects at Month 24 Time to first documented relapse Proportion of subjects treated with glucocorticoids due to relapses Time to confirmed Expanded Disability Status Scale (EDSS) progression at 12 months Time to confirmed Expanded Disability Status Scale (EDSS) progression at 24 months Proportion of subjects free from confirmed EDSS progression at 12 months Proportion of subjects free from confirmed EDSS progression at 24 months Mean number of Combined Unique Active (CUA) lesions per subject per MRI scan at Month 12 Mean number of Combined Unique Active (CUA) lesions per subject per MRI scan at Month 24 Mean number of new Gd-enhancing lesions per subject assessed by MRI at Month 12 Mean number of new Gd-enhancing lesions per subject assessed by MRI at Month 24 Frequency and severity of flu-like symptoms (FLS) as measured by FLS scale
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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)
Locations and Contacts
Investigational Site, Naples 80131, Italy
Additional Information
Starting date: April 2012
Last updated: September 11, 2014
|