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Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP 2 (PALADIN2)

NCT07726563 · National Taiwan University Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
10-20% of patients with ALS have anti-NRIP autoantibody and the titer of anti-NRIP autoantibody is correlated with motor functional decline and mortality in ALS. The PALADIN2 clinical trial is a single arm study, which intends to enroll 20 ALS patients having anti-NRIP autoantibody in plasma. Patients will receive 3 courses of plasmapheresis per 3 months in order to maintain low concentration of anti-NRIP autoantibody in plasma. The study will follow up these patients for another 6 months after plasmapheresis. This project will potentially confirm the efficacy and safety of plasmapheresis for ALS patients having anti-NRIP autoantibody.
Eligibility criteria
Inclusion Criteria: * ALS patients above 20-year-old who have anti-NRIP autoantibody in plasma * Agree to receive plasmapheresis treatment * Agree to participate in the study and receive serial examinations Exclusion Criteria: * Under permanent ventilator support * Cannot receive plasmapheresis treatment or serial examinations * Under pregnancy * Blood fibrinogen level below 50 mg/dl * Belong to special subtype of ALS, such as primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, flail leg syndrome.
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-19
Estimated completion: 2029-07-31
Last updated: 2026-07-24
Interventions
Device: plasmapheresis
Primary outcomes
  • Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) (12 months)
Sponsor
National Taiwan University Hospital · other
Contacts & investigators
ContactLi-Kai Tsai, MD, PhD · contact · milikai@ntuh.gov.tw · +886972651560
All locations (1)
National Taiwan University HospitalRecruiting
Taipei City, Taipei, Taiwan