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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02756104
Eligibility Criteria:
For the patients :
Inclusion Criteria:
* Man or woman with sporadic ALS and a possible, probable or definite diagnosis regarding the revised Escorial criteria (Forbes et al., 2001). Patients are followed quarterly according to national recommendations. At the end of the follow up period (1 year for each patient), all patients remaining in the " possible " group of diagnosis will be excluded.
* Disease onset (date of onset of muscle weakness) \< 18 months at the time of inclusion.
* Age: 30 to 80 years-old, inclusive.
* Patient treated by riluzole at a steady dosage since at least 3 months.
* Patient accepting to give informed consent
Exclusion criteria will be :
* A previous treatment with VD in the preceding 2 years, whatever the dose used.
* Patient with an already known autoimmune disorder
* Patient with severe ALS involvement suggesting that survival over the 1 year follow up is highly unlikely (ex : tetraplegia, use of non-invasive ventilation for more than 10 hrs/day, ALSFRS-R (ALS Functional Rating Scale) score \< à 20).
* Pregnant or breast-feeding woman.
* Patient without social security insurance
For the Controls:
Controls will be spouses of our ALS patients. Such a group has the advantage of similar life style conditions, and frequently similar geographical origin. Controls and ALS patients will match for age and gender. Controls will also fulfill the following inclusion and exclusion criteria
Inclusion criteria
•Subject accepting to give informed consent
Exclusion criteria
* Subject with an already known neurodegenerative disorder
* Subject with an already known autoimmune disorder
* Subject who received a treatment with VD in the preceding 2 years, whatever the dose used.
* Pregnant or breastfeeding woman
* Subject without social security insurance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT02756104
Study Brief:
Protocol Section:
NCT02756104