NCT07726563

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
36mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
May 2026Jul 2029

First Submitted

Initial submission to the registry

May 19, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 19, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

July 24, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

May 19, 2026

Last Update Submit

July 21, 2026

Conditions

Amyotrophic Lateral Sclerosis (ALS)AutoantibodyPlasmapheresis

Keywords

amyotrophic lateral sclerosisanti-NRIP autoantibodyplasmapheresis

Outcome Measures

Primary Outcomes (1)

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

    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

    12 months

Secondary Outcomes (12)

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

    15 months

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

    6 months

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

    12 months

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

    15 months

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

    15 months

  • +7 more secondary outcomes

Study Arms (1)

ALS patients with anti-NRIP autoantibody

EXPERIMENTAL
Device: plasmapheresis

Interventions

plasmapheresisDEVICE

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

ALS patients with anti-NRIP autoantibody

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei City, Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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: 33773096BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Component RemovalTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Central Study Contacts

Li-Kai Tsai, MD, PhD

CONTACT

+886972651560milikai@ntuh.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

July 24, 2026

Study Start

May 19, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

July 31, 2029

Last Updated

July 24, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After the end of the study

Locations

TW(1)