The HAM Ciclosporin Study: An observational trial of therapy in early or progressing HAM/TSP - HAM Ciclosporin

Imperial College0 个研究点目标入组 7 人开始时间: 2006年5月5日最近更新: 2019年11月25日

试验速览

暂无简介。

•Have ‘definite’ HAM/TSP that is either early or progressing disease as defined below
•Are able to give informed consent
•Are 16 years or older
•HAM/TSP” Patients with HAM/TSP will be included if they fulfil the criteria of Definite HAM/TSP” as agreed in Belem 2003. See annex.
•Early HAM/TSP” Less than 2 years history of disease, excluding the duration of bladder symptoms if these were the original and only presenting symptoms as assessed by history. Must have motor disability (minimum of stiffness or weakness).
•Progressing HAM/TSP” New or worsening (must be current within 3 months) motor symptoms in a patient with symptoms of greater than 2 years duration. Including a documented deterioration in timed walk by 50%. Patients with new symptoms under follow up could be included immediately. New patients presenting for initially with symptoms > 2 yrs would be eligible upon review if progression according to these criteria were met.
•Are the trial subjects under 18? yes
•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) yes
•F.1.3.1 Number of subjects for this age range

•Hepatitis B or hepatitis C infection
•HIV infection
•Badly controlled hypertension (BP diastolic > 95 mmHg)
•Overt sepsis
•Prior exposure to corticosteroids (other than 3 days courses of pulsed methylprednisolone) or other immunomodulating therapy for HAM/TSP or within 2 years if not for HAM/TSP
•Active TB (untreated or on treatment)
•Strongyloides stercoralis (untreated)

发起方

Imperial College