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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01428505
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female, aged 20-70
2. Able to read, comprehend and record information written in English.
3. Capable of giving written informed consent
4. Provide a venous blood sample that will be used for genetics research and the in vitro ligand binding assay.
5. A female subject is eligible to participate if she is willing to follow contraception guidelines or if she is of non-childbearing potential.
6. Male subjects must agree to use one of the contraception methods
MS subjects:
1. Clinical or clinical and laboratory supported diagnosis of multiple sclerosis
2. EDSS score up to and including 7.5 at screening evaluation
Healthy Volunteers:
1\. Healthy control subjects defined as free from clinically significant active disease as assessed by the Principal Investigator from their medical and psychiatric past and present history
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Exclusion Criteria:
1. If female, positive urine pregnancy test
2. An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2
3. History or presence of a neurological diagnosis
4. Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with radiation exposure.
5. Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
6. Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff.
7. Any subject the investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities or subject's unwillingness to comply with all study-related procedures).
8. Contraindications to MRI scanning
9. Any physical abnormality or functional disability which prevents the subject from acquiring a suitable position for scanning.
10. History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera or MRI scanner for a period of at least 90mins.
11. Unwillingness or inability to follow the procedures outlined in the protocol. -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01428505
Study Brief:
Protocol Section:
NCT01428505