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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02059759
Eligibility Criteria:
Inclusion Criteria:
* The patient has been correctly informed
* The patient must have given his/her informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least 18 years old and less than 75 years old
* Probable, or laboratory-supported probable or definite ALS as defined by El Escorial Revised ALS diagnostic criteria (according to Airlie House Conference 1988)
* Stable on riluzole treatment for more than 3 months with liver function test results \< 2ULN
* Disease duration ≤ 5 years
* Vital capacity ≥ 70% of normal
* Ability to swallow without the requirement for nasogastric or PEG feeding
* Agreement for patient to use an adequate method of contraception throughout the study and for 2 weeks after post study visit
* The patient is available and willing to participate in seven study visits occurring at the CHU within the next six months
Exclusion Criteria:
* The patient is participating in another interventional study
* Within the past three months, the patient has participated in another interventional
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection
* The patient is an adult under guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Other life threatening disease
* Presence of contra-indicated concomitant treatments or with potential neuroprotective benefit (see section 11.2 of the protocol)
* Presence of tracheostomy or non-invasive ventilation
* Use of Percutaneous endoscopic gastrostomy (PEG) or nasogastric tube
* Presence of clinical infection (treated or untreated)
* Positive serology for CMV, EBV (confirmed by viral load), or HIV
* Vaccination within 8 weeks prior to first experimental dosing
* Other disease precluding functional assessments
* Cancer within the past 5 years (except stable non-metastatic basal cell skin carcinoma or in situ carcinoma of the cervix)
* Severe cardiac or pulmonary disease
* Documented auto-immune disorders except asymptomatic Hashimoto thyroiditis
* Women of child bearing age without contraception or pregnant or breast feeding
* Any clinically significant laboratory abnormality (excepting cholesterol, triglyceride and glucose)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02059759
Study Brief:
Protocol Section:
NCT02059759