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

• Conditions: AMYOTROPHIC LATERAL SCLEROSIS; MedDRA version: 9.1Level: LLTClassification code 10002026Term: Amyotrophic lateral sclerosis

• Registration Number: EUCTR2007-001592-10-IT
• Lead Sponsor: ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if the addition of TUDCA to the conventional therapy can improve the therapeutic outcome in patients affected by ALS (ALSFRS-R).<br>Safety will be assessed for all subjects, for the entire duration of the study.;Secondary Objective: Secondary parameters will include FVC%, the SF-36 quality of life rating scale, Time to Tracheostomy from starting of study medication<br>dosing (if appropriate), Survival Time from starting of study medication dosing (if appropriate) and the number of patients<br>showing an improvement &#8805; 15% in ALSFRS-R slope as compared to the lead-in period (responders).;Primary end point(s): Primary evaluation parameter will be the ALSFRS-R (2) according to the consensus conference on designing and implementing clinical<br>trials in ALS (3).<br>Primary endpoint will be the ALSFRS-R slope during the treatment period as compared to the lead-in period