EUCTR2006-006465-16-DE进行中（未招募）1 期
Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MS
niversity of Leipzig0 个研究点开始时间: 2007年5月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18-55 years (included), female or male
- •MS according to McDonald criteria, 2005 revision (Polman et al., 2005)
- •Relapsing-remitting (RRMS) or secondary progressive (SPMS) course
- •EDSS 0 – 5.5 (included)
- •Time since resolution of the last relapse or dose of corticosteroid treatment at least six weeks
- •Time since onset of a clinically manifest episode of optic neuritis at least one year
- •Pathological prolongation of visual evoked potentials on at least one eye, documented to be stable for at least three months
- •On screening MRI, at least three supratentorial lesions in T2/FLAIR
- •All patients must give written consent for participation in the study prior to the screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Primary progressive course of MS (PPMS)
- •More than four Gd contrast enhancing lesions on screening MRI
- •Ophthalmologic condition associated with impaired visual acuity, visual field cuts or other impairment of visual function, other than related to MS; glaucoma stable under regular treatment is acceptable
- •Treatment with an immunosuppressive agent (azathioprine, mitoxanthrone, methotrexate), natalizumab or any monoclonal antibody within six months before start of rhGH treatment
- •History of chronic disease of the immune system other than MS or of a known immunodeficiency syndrome
- •Diabetes mellitus, pathological percentage of HbA1c at screening
- •Patients with a history of malignancy or lymphoproliferative disorder, or current malignant tumor of any type or location
- •Patients unable to undergo MRI scans, including claustrophobia or history of severe hypersensitivity to gadolinium
- •Dementia/severe cognitive deficits
- •Patients with thyroid diseases (unless an individual consultion with an endocrinologist justifies participation)
- •Contraindication to the planned therapy (e. g. hypersensitivity to trial medication or one of its components)
- •Ongoing drug abuse
- •HIV positive
- •Pregnant or nursing women
- •Women with child bearing potential without effective contraception (a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed).
- •Expected low compliance
- •Concomitant participation in other clinical trials
- •Contraindication to the planned therapy as per Summary of Prescribing Information (Fachinformation): Suspected progression or reappearance of intra-cranial mass lesions; patients suffering from acute major disease, which resulted from experiencing complications after heart or abdominal surgery, after multiple accidental trauma or respiratory failure; Prader-Willi-Syndrome
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