Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07726563

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Autoantibody Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Plasmapheresis Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plasmapheresis

Device

Using plasmapheresis to remove plasma anti-NRIP autoantibody; each patient receive 3 courses of plasmapheresis with 3 months apart

Primary outcomes

  1. Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)

    Time frame: 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

  1. Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)

    Time frame: 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

  2. Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)

    Time frame: 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

  3. Change in disease severity measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)

    Time frame: 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

  4. Change in disease progression rates measuring using MRC (Medical Research Council score) mega-score

    Time frame: 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

  5. Change in disease progression rates measuring using Grips force (lb)

    Time frame: 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

  6. Change in disease progression rates measuring using 6MWT (6 minute walking test); distance in meters

    Time frame: 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

  7. Change in disease progression rates measuring using EQ-5D (EuroQol Group Life Quality Score)

    Time frame: 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

  8. Change in disease progression rates measuring using respiratory vital capacity (standardized vital capacity, %)

    Time frame: 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

  9. Change in disease progression rates measuring using CMAP (compound muscle action potential, mV)

    Time frame: 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

  10. Change in disease progression rates measuring using MUNE (motor unit number estimation; number)

    Time frame: 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

  11. Change in disease severity measuring using plasma NF-L (Neurofilament-light chain; pg/mL)

    Time frame: 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

  12. Any side effect under plasmapheresis

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Li-Kai Tsai, MD, PhD

CONTACT

[email protected]

+886972651560

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Acronym: PALADIN2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.