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)
概览
- 阶段
- 2 期
- 干预措施
- IFN beta 1a 44 mcg TIW
- 疾病 / 适应症
- Multiple Sclerosis
- 发起方
- Merck KGaA, Darmstadt, Germany
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
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.
详细描述
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).
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IFN beta 1a 44 mcg TIW + curcumin (BCM95)
干预措施: IFN beta 1a 44 mcg TIW
IFN beta 1a 44 mcg TIW + curcumin (BCM95)
干预措施: Curcumin
IFN beta 1a 44 mcg TIW + placebo
干预措施: IFN beta 1a 44 mcg TIW
IFN beta 1a 44 mcg TIW + placebo
干预措施: Placebo
结局指标
主要结局
Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12
时间窗: 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.
次要结局
- Median Change From Baseline in Regional Brain Volume at Month 12 and 24(Baseline, 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 Relapse-Free Subjects at Month 12 and Month 24(Month 12 and 24)
- Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24(Month 24)
- Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24(Month 12 and 24)
- 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)
- Flu-like Symptoms (FLS) Assessed by FLS Scale Score(Screening, Baseline, Month 3, 6, 12 and 24)
- Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation(Baseline up to Month 24)
- Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24(Month 12 and 24)
- Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24(Month 12 and 24)
- Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24(Month 12 and 24)
- Cumulative Number of New T1 (Hypointense) Lesions(Baseline up to Month 24)
- Median Change From Baseline in Whole Brain Volume at Month 12 and 24(Baseline, Month 12 and 24)
- Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters(From screening up to Month 24)
- Number of Subjects With One Concomitant Medication From Baseline up to Month 24(Baseline up to Month 24)
- Time on Treatment (Adherence to Treatment)(Baseline up to 2.2 years)
- Number of Subjects With Premature Termination From Treatment(Baseline up to Month 24)
- Hazard Ratio for Time to First Documented Relapse(Baseline up to Date at which first Relapse Occurs assessed up to 24 months)