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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02011204
Eligibility Criteria:
Early ALS Inclusion Criteria:
* Sporadic or familial ALS (as defined by revised El Escorial criteria)
* Onset of weakness or spasticity due to ALS ≤ 36 months prior to the Screening/Baseline Visit.
* Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age
Early ALS Exclusion Criteria:
\- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
ALS Disease Mimics Inclusion Criteria:
\- Diagnosis of one of the following:
a. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii. Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness involving more than one extremity or more than a single myotome if restricted to one extremity.
iv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth Disease vi. Any condition that produces generalized or localized weakness without concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating physician deems mimics ALS.
b. Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple sclerosis iii. Hereditary spastic paraparesis
ALS Disease Mimics Exclusion Criteria:
* Diagnosis of possible, probable, probable-laboratory supported, or definite ALS
* Presence of positive family history of ALS.
* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
Healthy Volunteer Inclusion Criteria:
\- Absence of a known neurological disorder.
Healthy Volunteer Exclusion Criteria:
* History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative disease.
* Presence of positive family history of ALS.
* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
\*Please note that this is not a complete listing on all eligibility criteria.\*
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT02011204
Study Brief:
Protocol Section:
NCT02011204