NCT02273635Unknown1 期
Controlled, Randomized, Double-blind Clinical Trial, 24 Months Duration, to Compare the Efficacy, Safety and Tolerability of Andrographolide Versus Placebo in Patients With Progressive Forms of Multiple Sclerosis
Innobioscience SpA1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Brain atrophy in patients with progressive forms of MS
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg administered twice a day orally versus a placebo as a modifying treatment of the disease in patients with the progressive forms of Multiple Sclerosis (MS).
The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.
详细描述
- Evaluate the clinical efficacy of andrographolide 140 mg administered orally twice a day versus a placebo in:
- Delay in the disability capacity progression through the Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) at 24 months compared to the baseline.
- Delay in cognitive impairment by means of Paced Auditory Serial Addition Test (PASAT), Symbol Digit Modalities Test (SDMT) and depression (Beck) at 24 months compared to the baseline.
- Quality of life Multiple Sclerosis Impact Scale (MSIS 29) and fatigue (Krupp) through parameters reported by the patients at at 24 months compared to the baseline.
- Tolerability of andrographolide measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 months.
- Delay in the decrease in brain volume measured by Magnetic Resonance (MR) at 24 months compared to the baseline.
- Number and volume of new lesions or larger size in T2 by MR at 24 months compared to the baseline.
- Number of new hipointense lesions in T1 or (gadolinium captive) by MR at 24 months compared to the baseline.
- Delay in the retineal thinning measured by Optical Coherence Tomography (OCT) and visual field at 24 months compared to the baseline.
- Safety of andrographolide at 24 months through the record of adverse effects in symptom dairy and programmed interviews.
- Explore the pharmacokinetic of andrographolide 140 mg administered orally twice day in:
- bio availability and concentration of andrographolide in the patients with treatment.
- half-life, maximum concentration, clearance of andrographolide in equilibrium state.
- Determine the immunomodulatory effects of andrographolide 140 mg administered twice a day orally on lymphocyte populations in patients through the:
- Determination of Th1, Th2, Th17 and Treg lymphocyte sub-populations.
- Determination of cytokines IFNgama, TNFalpha, IL2, IL17alpha and TGFbeta.
Population: adult patients, men and women with progressive forms of MS. The number of patients to be selected will be 68, to randomly assign 34 patients to each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent previous to the initiation of the study before any evaluation.
- •Men and women > 18 years of age with Minimental >
- •Patients with diagnosis of secondary progressive MS without relapses or primary progressive MS according to the criteria of McDonald 2010.
排除标准
- •Relapsing-remitting MS
- •Current Immunomodulatory or immunosuppressive therapy
- •Uncontrolled systemic diseases not controlled or treated with immunotherapy (i.e Rheumatoid Arthritis, Lupus Erythematosus).
- •Pregnant women
研究组 & 干预措施
andrographolides
Experimental
Coated tablets containing 140 mg andrographolides twice a day orally administered for a period of 24 months.
干预措施: Andrographolides (Drug)
sugar tablets
Placebo Comparator
Coated tablets containing 140 mgs excipients twice a day orally administered for a period of 24 months.
干预措施: placebo (Drug)
结局指标
主要结局
Brain atrophy in patients with progressive forms of MS
时间窗: 24 months
Retarding the progression of brain atrophy as measured by MR quantified by the percentage of change in volume size utilizing SIENA.
次要结局
- Number of new T2 lesions(24 months)
- Fatigue by Krupp scale(24 months)
- Expanded Disability Status Scale (EDSS)(24 months)
- Multiple Sclerosis Functional Composite (MSFC)(24 months)
- New hypointense lesions in T1(24 months)
- Record of adverse effects in daily symptoms and programmed interviews.(24 months)
- Depression by Beck scale(24 months)
- Visual field(24 months)
- Paced Auditory Serial Addition Test (PASAT)(24 months)
- Quality of life Multiple Sclerosis Impact Scale (MSIS 29)(24 months)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(24 months)
- Optical Coherence Tomography (OCT)(24 months)
- Number of new gadolinium enhancement lesions in T1 by MR(24 months)
- Symbol Digit Modalities Test (SDMT)(24 months)
- Volume of new T2 lesions(24 months)
研究者
研究点 (1)
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