A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis.

St. Vincent's University Hospital0 个研究点目标入组 80 人开始时间: 2012年2月9日最近更新: 2020年11月23日

适应症

试验速览

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•Patients with SPMS or PPMS, aged 18-70, who have Kurtzke EDSS scores in the range 4.0 to 7.0 inclusive and a walking speed with or without aids in the T25FW of 8.0 to 14.0 seconds and evidence of significant upper limb dysfunction as defined by a 9HPT of 15 – 90 seconds (dominant or non-dominant hand), will be recruited.
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1) Patients with a history of seizures, significant liver dysfunction, significant renal dysfunction, significant upper or lower limb arthritis or any other disorder including cognitive dysfunction which would affect the ability to accurately complete questionnaires and give full informed consent.
•2) Patients with clinically significant upper limb ataxia or upper limb proprioceptive sensory loss, which in the opinion of the Clinician affect upper limb functional assessment.

发起方