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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT01855594
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 65;
* Diagnosis of traumatic spinal cord injury;
* Clinically diagnosed neuropathic pain;
* Pain severity is at least 4 on a 11-point numeric rating scale at screening;
* Pain present regularly for at least 6 weeks before enrollment;
* Able to understand instructions and provide reliable pain assessments;
* Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form;
Exclusion Criteria:
* Significant renal, cardiovascular, hepatic, infectious or psychiatric disease;
* Significant brain injury with neurological deficits;
* Debilitation or dehydration;
* Addison's disease;
* Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines;
* A history of substance or alcohol abuse within past 1 year;
* A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period;
* Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control;
* Participation in any drug study in the last three months;
* History of oral lithium intake for any reason; or
* any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01855594
Study Brief:
Protocol Section:
NCT01855594