Exploratory Trial of Forza™️, a Novel Nutraceutical From Actinidia Deliciosa Plants Bioengineered to Bio-encapsulate the Osmotin Plant Protein as Adjuvant for the Treatment of Progressive Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Incidence and severity of treatment-related adverse events after 1 month of therapy.
研究概览
简要总结
The aim of this study is to explore the anti-inflammatory and neuroprotective effects of a novel nutraceutical product (commercial name Forza™️), consisting of the plant osmotin protein, in patients with progressive multiple sclerosis (PMS). The potential effect on brain metabolism and microstructure will be evaluated by magnetic resonance imaging (MRI) performed six months before starting treatment, at baseline, and after one and six months of treatment. At the same timepoints, electrophysiology, neurofilaments (NfL) quantification, optical coherence tomography (OCT) and clinical assessments will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 written informed consent
- •Diagnosis of progressive multiple sclerosis (PMS)
- •Expanded Disability Status Scale EDSS ≤ 6.5
排除标准
- •Contraindications to MRI
- •Pregnancy
- •HIV positivity
- •Severe renal, hepatic, oncological, hematological and psychiatric diseases
结局指标
主要结局
Incidence and severity of treatment-related adverse events after 1 month of therapy.
时间窗: 1 month (after 1 month of treatment).
Incidence and severity of treatment-related adverse events after 6 months of therapy.
时间窗: 6 months (after 6 months of treatment).
次要结局
- Change in Timed 25 Foot Walk (T25FW).(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in 12-item Multiple Sclerosis Walking Scale (MSWS12).(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in Nine-Hole Peg Test (9HPT).(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in patient self-evaluation of depression and anxiety recorded with Hospital Anxiety Depression Scale (HADS).(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in Expanded Disability Status Scale (EDSS).(12 months (6 month before starting treatment, at baseline and both after one month and six months of treatment))
- Change in Montreal Cognitive Assessment (MOCA).(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- The impact of Forza™️ on retinal atrophy in PMS.(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in Symbol Digit Modalities Test (SDMT).(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in bladder domain function recorded with Overactive Bladder (OAB) questionnaire.(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in serum neurofilament Light Chain (NfL) levels to verify the neuroprotective action of Forza™️ in PMS.(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in brain microstructure.(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- The impact of Forza™️ on neurophysiology in PMS.(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
- Change in brain metabolism as concentration of glutamate, N-acetylaspartate, creatine and choline.(12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment))
研究者
Matilde Inglese
Clinical Professor, Principal Investigator
Ospedale Policlinico San Martino