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Recruiting NCT07726563

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

No phase Interventional Amyotrophic Lateral Sclerosis (ALS) Autoantibody Plasmapheresis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: plasmapheresis.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis (ALS), Autoantibody, Plasmapheresis. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [Time frame: 12 months]
Secondary outcome measures (12)
  • Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [Time frame: 15 months]
  • Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [Time frame: 6 months]
  • Change in disease severity measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) [Time frame: 12 months]
  • Change in disease progression rates measuring using MRC (Medical Research Council score) mega-score [Time frame: 15 months]
  • Change in disease progression rates measuring using Grips force (lb) [Time frame: 15 months]
  • Change in disease progression rates measuring using 6MWT (6 minute walking test); distance in meters [Time frame: 15 months]
  • Change in disease progression rates measuring using EQ-5D (EuroQol Group Life Quality Score) [Time frame: 15 months]
  • Change in disease progression rates measuring using respiratory vital capacity (standardized vital capacity, %) [Time frame: 15 months]
  • Change in disease progression rates measuring using CMAP (compound muscle action potential, mV) [Time frame: 15 months]
  • Change in disease progression rates measuring using MUNE (motor unit number estimation; number) [Time frame: 15 months]
  • Change in disease severity measuring using plasma NF-L (Neurofilament-light chain; pg/mL) [Time frame: 12 months]
  • Any side effect under plasmapheresis [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei City

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

Identifiers

NCT: NCT07726563 · 202502154DINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗