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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01142856
Eligibility Criteria:
Inclusion Criteria:
* age greater than 18 years, if female, must be menopausal or had hysterectomy
* resident and citizen of the United States
* history of a chronic onset of a progressive motor weakness
* able to comply with protocol requirements
* can provide written consent
Exclusion Criteria:
* does not have renal disease (Creatine \> 2.0)
* does not have active systemic disease
* does not have any clinically significant abnormalities on prestudy laboratory evaluation
* does not have any clinically significant medical condition (e.g.,within 6 months of baseline, had a myocardial infarct, angina pectoris, and/or congestive heart failure), that in the opinion of the investigator, would compromise the safety of the patient
* does not have a history of cancer including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion,or re-occurrence within 3 years of baseline).
* has not used an investigational drug within 30 days of baseline visit
* does not have a tracheostomy
* does not have a Beck's Depression Inventory score \>16
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01142856
Study Brief:
Protocol Section:
NCT01142856