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:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT01935518
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of laboratory-supported probable, probable, or definite ALS
* Age: 18-70 years
* Disease duration: 3-36 months
* Forced vital capacity: at least 60% of predicted
* ALSFRS-R: at least 30, respiratory items: at least 10
* Decline of ALSFRS-R in the last 3 months before enrollment: 1-8
* Must take riluzole, on a stable dose for at least 30 days prior to baseline visit with no serious side effects. They must continue the riluzole treatment for at least 6 months after enrollment.
* Patients of childbearing potential must be using an effective method of birth control
* Willing and able to give informed consent
Exclusion Criteria:
* Familial ALS
* Pregnant or nursing women
* Patients after tracheotomy or continuous ventilator-dependent (time with non-invasive ventilator more than 22 hours per day for 7 consecutive days.)
* After percutaneous endoscopic gastrostomy
* Alanine Transaminase (ALT) or Aspartate Transaminase (AST): at least 3 times the upper limit of normal
* Abnormal creatinine or urea nitrogen
* Severe cardiac disease, pulmonary disease, hematic disease, autoimmune disease, mental disease, dementia and substance abuse
* History of malignancy
* History of intracranial hemorrhage
* History of severe bleeding of digestive tract, lungs, nose and skin
* Allergic to fasudil
* Participating in other clinical studies or using other investigational drugs at present
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01935518
Study Brief:
Protocol Section:
NCT01935518