Phase II Study of Linoleic Acid in Relapsing Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Within patient change in the sum of gadolinium-enhancing lesions on brain MRIs obtained during the treatment period compared to pre-treatment.
研究概览
简要总结
Several investigations have suggested that polyunsaturated fatty acids may promote therapeutic effects in MS. This pilot study will determine whether omega-6 polyunsaturated fatty acids (PUFAs),in the form of linoleic acid,can reduce disease activity and prevent disability progression in patients with relapsing MS.This study will seek to measure disease activity as seen on MRI scans in addition to measuring relapse rates.
详细描述
Participants who meet inclusion criteria will start placebo treatment by taking olive oil for 2 months. This period will include screening activities including 3 monthly MRIs. Those with 2 enhancing lesions on three placebo run-in period MRIs will continue in the study and receive omega-6 PUFA (linoleic acid) for 6 months. Brain MRIs will be repeated after 4,5, and 6 months after treatment.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Relapsing MS
- •treated with FDA-approved dosage of interferon-beta (Avonex,Betaseron,Rebif), glatiramer acetate for at least 6 months OR no immunotherapy for at least 3 months
- •at least one clinical exacerbation or at least one gadolinium enhancing lesion on brain MRI in the past 12 months
- •at least two gadolinium enhancing lesions on three brain MRIs obtained during the placebo run-in period
- •women of childbearing potential may participate provided that they are using adequate birth control methods for the duration of the study. Women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating.
- •willing and able to provide informed consent
排除标准
- •corticosteroids within 1 month prior to screening
- •treatment with other immunotherapies (other than interferon-beta, glatiramer acetate or sporadic corticosteroids) within 3 months prior to screening
- •any significant medical condition or laboratory abnormality which may interfere with the subject's ability to participate in the study, including peptic ulcer disease, avascular necrosis and hepatic insufficiency
- •history of hypersensitivity or intolerability to vegetable oils or their constituents
- •unable to perform any of the required study procedures
研究组 & 干预措施
1
placebo/active crossover
干预措施: Linoleic Acid/Oleic Acid (Drug)
结局指标
主要结局
Within patient change in the sum of gadolinium-enhancing lesions on brain MRIs obtained during the treatment period compared to pre-treatment.
时间窗: 9 months
次要结局
- Annualized relapse rate(9 months)
- Changes in depression and fatigue symptoms on standardized questionnaires (Beck Depression Scale and Modified Fatigue Impact Scale).(9 months)
- Changes in T2 lesion counts/volume, change in T1 hypointense lesion counts/volume, white matter volume and gray matter volume(9 months)
研究者
Andrew Goodman
MD
University of Rochester