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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04057456
Eligibility Criteria:
Inclusion:
1. Age 25 and over, based on year of birth
2. Signed informed consent obtained prior to any study-related activities
3. BMI 18-40
4. A spinal cord injury at least 12 months duration, nonprogressive for at least 6 months
5. At- and/or below-level neuropathic pain \>3/10 in severity on the numeric rating scale (NRS) (below-level neuropathic pain will be defined as pain \>1 dermatomal level below the neurologic level of injury). Participants will need an average \>3/10 pain over the past 7 days on screening, and to complete a daily diary for the week prior to randomization in the morning with an average pain severity of \>3/10 on at least 4 diary entries.
6. Ongoing constant pain for at least 3 months, or relapsing/remitting pain for at least 6 months.
7. Dosing of other pain medications (NSAIDs, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry.
8. Any cannabinoids, or cannabinoid medications (e.g. nabilone) will need to be stopped at least 1 month prior to screening for and inclusion in the study.
9. Females of childbearing potential must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods and double-barrier method) and must have a negative pregnancy test results at screening and baseline.
Exclusion:
1. History of psychotic disorder
2. History of convulsive disorders
3. History of substance abuse
4. experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months
5. Significantly impaired hepatic function at Visit A1 or B1 (Alanine aminotransferase \[ALT\] \>5 upper limit of normal \[ULN\] or total bilirubin \[TBL\] \>2 ULN) OR the ALT or Aspartate aminotransferase (AST) \>3 ULN and TBL \>2 ULN (or international normalized ratio \[INR\] \>1.5)
6. Female patients of child bearing potential and male patients whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, during the study and for three months thereafter
7. Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
8. Current suicidal ideation
9. Current use of cannabinoids or cannabinoid medication
10. Intolerance to cannabinoids
11. Traumatic SCI superimposed on prior congenital stenosis
12. Preexisting myelopathy of other causes (e.g. transverse myelitis, epidural abscess, congenital spondylotic myelopathy)
13. Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI
14. Currently enrolled in another clinical trial
15. Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study
16. Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT04057456
Study Brief:
Protocol Section:
NCT04057456