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Extracorporeal Photopheresis (ECP) in the Treatment of Stiff Person Syndrome (OPTION Study)

NCT06703333 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2026-08-06

No results posted yet for this study

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).

Conditions

  • Stiff Person Syndrome

Interventions

COMBINATION_PRODUCT

Extracorporeal photopheresis (ECP)

* Months 1-3: One ECP cycle (two-consecutive days) every other week for 3 months (12 procedures). * Months 4-6: One ECP cycle every month for 3 months (6 procedures). * Total: 18 procedures (within 6 months \~24 weeks).

Sponsors & Collaborators

  • Yandy Marx Castillo Aleman

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-04-30
Completion
2027-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United Arab Emirates

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06703333 on ClinicalTrials.gov