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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT06703333
Eligibility Criteria:
Inclusion Criteria:
* Documented history of classical SPS with serum and CSF anti-GAD antibodies.
* Age ≥ 18 ≤ 75 years.
* Weight ≥ 50 kg.
* Hematocrit ≥ 30 % (with or without transfusion support).
* Platelet count ≥ 100 x 10\^3/uL (with or without transfusion support).
* Willingness to use at least one reliable method of birth control (e.g., abstinence, oral contraceptives, intrauterine devices, barrier method with spermicide, or surgical sterilization) throughout the study for all men and women of childbearing potential.
* Willingness to participate in all study tests, visits, and procedures (including ECP), as outlined in the informed consent.
* Adequate peripheral venous access to initiate ECP therapy.
* The patient agrees to participate in the trial and signs the informed consent form.
Exclusion Criteria:
* Progressive encephalomyelitis with rigidity and myoclonus (PERM).
* Paraneoplastic variants of SPS.
* Concurrent diagnosis of a neurological condition that would interfere with the assessment of SPS.
* Women who are pregnant and/or lactating.
* Absolute medical contraindication to receive ECP.
* Hypersensitivity or allergy to psoralen (methoxalen).
* Hypersensitivity or allergy to heparin.
* Previous history of heparin-induced thrombocytopenia.
* Aphakia or photosensitive disease (systemic lupus erythematosus, porphyrias, etc.).
* Laboratory evidence of any of the following:
* Mononuclear cell (MNC) count \<2.0 x 10\^3 cells/uL.
* Serum transaminase levels \> x 2 UNL.
* Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m2.
* Evidence of known infection with human immunodeficiency virus (HIV) or hepatitis B.
* Uncontrolled infection requiring treatment at study entry.
* Use of any investigational drug/treatment at the time of enrollment or within the previous 60 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
* Previous history of skin cancer, leukemia / lymphoma / myeloma, or bone marrow transplant.
* Any other disease or condition which, in the opinion of the investigator, could interfere with participation according to the study Protocol, or with the ability of the patients to cooperate and comply with study procedures.
* Inability to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06703333
Study Brief:
Protocol Section:
NCT06703333