Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00877604
Eligibility Criteria:
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);
* first symptoms of ALS by no more than 1.5 years;
* in treatment with steady regimen of riluzole 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.
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;
* subjects with bulbar onset;
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00877604
Study Brief:
Protocol Section:
NCT00877604