A randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholicacid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALS

ISTITUTO NEUROLOGICO CARLO BESTA0 个研究点开始时间: 2008年1月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Caucasian male or female out-patients;
•aged 18 to 75 years inclusive;
•diagnosis of ?probable? or ?definite? amyotrophic lateral sclerosis according to the El Escorial revised criteria (1);
•experiencing disease progression in the last 3 months;
•first symptoms of ALS by no more than 1.5 years;
•in treatment with steady regimen of riluzole and vitamin E for a minimum of 3 months before study entry, and desiring its continuation;
•FVC ≥ 75% of predicted;
•no conditions known to be contraindications to the use of TUDCA;
•written informed consent.
•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) yes
•F.1.3.1 Number of subjects for this age range

•subjects who underwent tracheostomy;
•subjects who underwent resection of gall bladder;
•subjects with signs of conduction blocks of motor nerves, sensory nerves or both on nerve conduction study;
•subjects with clinical signs of dementia;
•subjects with active peptic ulcer;
•subjects with active malignancy;
•female subjects who are pregnant or lactating
•subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening
•employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of
•that investigator or study centre.

发起方

ISTITUTO NEUROLOGICO CARLO BESTA