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OpenTrials
Completed

NCT Number: NCT05562960

Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

Patient with amyotrophic lateral sclerosis (ALS) having anti-NRIP autoantibody showed titer-dependent detrimental Effects. Plasmapheresis might benefit this subgroup of patients via removal of anti-NRIP autoantibody

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Key information

Conditions

Amyotrophic Lateral Sclerosis 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

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with amyotrophic lateral sclerosis (ALS) at the age more than 20 years and having plasma anti-NRIP autoantibody.
  • Agree to receive plasmapheresis intervention.
  • Agree to participate in the trial and receive serial examinations and follow up.

Exclusion criteria

  • Patients without plasma anti-NRIP autoantibody.
  • Patients requiring permanent ventilator support for ALS progression.
  • Not able to receive plasmapheresis or trial-related examinations.
  • Under pregnancy.
  • Blood fibrinogen level less than 50 mg/dl.
  • Specific ALS subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome.

Treatment and study plan

Plasmapheresis

Procedure

Regular plasmapheresis to remove anti-NRIP autoantibody

Primary outcomes

  1. Change in ALSFRS-R decline

    Time frame: Before (3-month) and after (3-month) intervention

    Change in ALSFRS-R decline before (3-month) and after (3-month) intervention. <ALSFRS-R indicates revised ALS functional rating scale, ranged from 0 to 48 with the higher, the better motor function>

Secondary outcomes

  1. Change in ALSFRS-R decline

    Time frame: Before (3-month) and after (6-month) intervention

    Change in ALSFRS-R decline before (3-month) and after (6-month) intervention

  2. Changes in ALSFRS-R score

    Time frame: Day 0 to days 30, 90, and 180

    Changes in ALSFRS-R score from day 0 to days 30, 90, and 180

  3. Change in force vital capacity

    Time frame: Before intervention and on day 90

    Change in force vital capacity before intervention and on day 90

  4. Change in compound motor action potentials

    Time frame: Before intervention and on day 90

    Change in compound motor action potentials before intervention and on day 90

  5. Changes in anti-NRIP titer

    Time frame: Day 0 to days 30, 90, and 180

    Changes in anti-NRIP titer from day 0 to days 30, 90, and 180

  6. Any adverse effect under plasmapheresis

    Time frame: Within 6 months during and after plasmapheresis

    Any adverse effect during and within 6 months after plasmapheresis

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Acronym: PALATIN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2022
Registry last updated
Jul 22, 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.

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