Extracorporeal Photopheresis (ECP) in the Treatment of Stiff Person Syndrome (OPTION Study) (NCT06703333) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Extracorporeal Photopheresis (ECP) in the Treatment of Stiff Person Syndrome (OPTION Study)
United Arab Emirates3 participantsStarted 2026-01
Plain-language summary
OPTION study is a pilot, open-label, prospective, and multicentric clinical trial involving outpatients with a diagnosis of classical stiff person syndrome (SPS), whereas extracorporeal photopheresis (ECP) is the investigational treatment. The study will be conducted at the Specialized Rehabilitation Hospital/Capital Health and Yas Clinic Khalifa City (YCKC) Hospital (managed by Abu Dhabi Stem Cells Center -ADSCC), clinical sites responsible for patient assessment and inclusion, and follow-up consultations, according to the approved Protocol, while YCKC will be the site in which patients will undergo the investigational intervention (ECP).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerability to ECP procedures
Timeframe: Weeks 0-24
2
Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) assessed by CTCAE v5.0.