| Registry | NCT07726563, acronym PALADIN2 |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 20 (Estimated) |
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| Sponsor | National Taiwan University Hospital (Other) |
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| Conditions | Amyotrophic Lateral Sclerosis (ALS), Autoantibody, Plasmapheresis |
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| Interventions | plasmapheresis (Device) |
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| Dates | start 2026-05-19, primary completion 2029-01-31 (estimated), completion 2029-07-31 (estimated), first posted 2026-07-24, last updated 2026-07-24 |
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| Locations | 1 site in Taiwan |
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Related Papers Related Patents Related Grants Related Experts
All trials for Amyotrophic Lateral Sclerosis (ALS) All trials for Autoantibody All trials of plasmapheresis
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| ALS patients with anti-NRIP autoantibody | Experimental | Device: plasmapheresis | |
- plasmapheresis (Device): Using plasmapheresis to remove plasma anti-NRIP autoantibody; each patient receive 3 courses of plasmapheresis with 3 months apart
+Outcome measures
Primary outcomes
- Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [12 months]: Difference between \[(ALSFRS-R at month -3 - ALSFRS-R at month 0)/3\] and \[(ALSFRS-R at month 0 - ALSFRS-R at month 9)/9\]; Months -3 to 0 vs. Months 0 to 9; the higher above ratio means higher disease progression rate
Secondary outcomes
- Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [15 months]: Difference between \[(ALSFRS-R at month -3 - ALSFRS-R at month 0)/3\] and \[(ALSFRS-R at month 0 - ALSFRS-R at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
- Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [6 months]: Difference between \[(ALSFRS-R at month -3 - ALSFRS-R at month 0)/3\] and \[(ALSFRS-R at month 0 - ALSFRS-R at month 3)/3\]; Months -3 to 0 vs. Months 0 to 3; the higher above ratio means higher disease progression rate
- Change in disease severity measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [12 months]: The ALSFRS-R at months 3, 6, 9,12 as compared to that at month 0; the lower the AFSFRS-R, the worse disease severity
- Change in disease progression rates measuring using MRC (Medical Research Council score) mega-score [15 months]: Difference between \[(MRC mega-score at month -3 - MRC mega-score at month 0)/3\] and \[(MRC mega-score at month 0 - MRC mega-score at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
- Change in disease progression rates measuring using Grips force (lb) [15 months]: Description: Difference between \[(Grips force at month -3 - Grips force at month 0)/3\] and \[(Grips force at month 0 - Grips force at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
- Change in disease progression rates measuring using 6MWT (6 minute walking test); distance in meters [15 months]: Difference between \[(distance at month -3 - distance at month 0)/3\] and \[(distance at month 0 - distance at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio, the higher disease progression rate
- Change in disease progression rates measuring using EQ-5D (EuroQol Group Life Quality Score) [15 months]: Difference between \[(Score at month -3 - Score at month 0)/3\] and \[(Score at month 0 - Score at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
- Change in disease progression rates measuring using respiratory vital capacity (standardized vital capacity, %) [15 months]: Difference between \[(vital capacity -3 - vital capacity at month 0)/3\] and \[(vital capacity at month 0 - vital capacity at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
- Change in disease progression rates measuring using CMAP (compound muscle action potential, mV) [15 months]: Difference between \[(CMAP -3 - CMAP at month 0)/3\] and \[(CMAP at month 0 - CMAP at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
- Change in disease progression rates measuring using MUNE (motor unit number estimation; number) [15 months]: Difference between \[(MUNE -3 - MUNE at month 0)/3\] and \[(MUNE at month 0 - MUNE at month 12)/12\]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
- Change in disease severity measuring using plasma NF-L (Neurofilament-light chain; pg/mL) [12 months]: The NF-L at months 3, 6, 9,12 as compared to that at month 0; the lower the NF-L, the milder disease activity
- Any side effect under plasmapheresis [12 months]
+Eligibility
Sex: All, ages: 20 Years to any
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.
+Locations (1)
| Facility | City | Country | Status |
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| National Taiwan University Hospital | Taipei City, Taipei | Taiwan | Recruiting |
+Publications
- Tsai LK, Chen IH, Chao CC, Hsueh HW, Chen HH, Huang YH, Weng RW, Lai TY, Tsai YC, Tsao YP, Chen SL. Autoantibody of NRIP, a novel AChR-interacting protein, plays a detrimental role in myasthenia gravis. J Cachexia Sarcopenia Muscle. 2021 Jun;12(3):665-676. doi: 10.1002/jcsm.12697. Epub 2021 Mar 26. PMID 33773096