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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT01854294
Eligibility Criteria:
Inclusion Criteria:
1. Patients with ALS: Familial and Sporadic ALS, with symptom onset \< or equal to 24 months.
2. At least 18 years of age
3. Subjects meet the El Escorial criteria of definite criteria for a diagnosis of ALS.
4. Subjects can be on a stable dose of riluzole for at least a month or not taking or initiating riluzole for the duration of the trial.
5. Not on any experimental medication for the last 1 month or five times the half-life of experimental medication.
6. At screening, must have a Forced Vital Capacity (FVC) ≥ 65% of predicted capacity for age, height and gender.
7. Have fully completed informed consent form
8. Ability to comply with study procedures
9. Women of child-bearing age must be on birth control. Pregnancy test should be done in women in child bearing age.
10. Medically safe to have lumbar puncture to collect CSF
Exclusion Criteria:
1. History of liver disease, severe renal failure, diabetes, coronary heart disease, cancer
2. Clinically significant EKG abnormality at screening
3. Any comorbid condition which would make completion of the trial unlikely
4. FVC \< 65%
5. Presence of a bleeding disorder
6. Allergy to local anesthetics
7. Problem with CSF pressure
8. Topical or other skin infection at the lumbar puncture site
9. BMI \> 32 kg/m2
10. Medical or surgical conditions in which a lumbar puncture is contraindicated
11. Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01854294
Study Brief:
Protocol Section:
NCT01854294