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Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP (PALATIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05562960
Recruitment Status : Not yet recruiting
First Posted : October 3, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Plasmapheresis Procedure: Plasmapheresis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
Estimated Study Start Date : November 1, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
ALS patients receiving plasmapheresis
Plasmapheresis in ALS patients with different titers of autoantibody against NRIP
 Procedure: Plasmapheresis
Regular plasmapheresis to remove anti-NRIP autoantibody


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients without plasma anti-NRIP autoantibody.
  2. Patients requiring permanent ventilator support for ALS progression.
  3. Not able to receive plasmapheresis or trial-related examinations.
  4. Under pregnancy.
  5. Blood fibrinogen level less than 50 mg/dl.
  6. Specific ALS subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05562960


Contacts
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Contact: Li-Kai Tsai, MD., Ph.D. 886-2-23123456 ext 63476 milikai@ntuh.gov.tw

Sponsors and Collaborators
National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT05562960    
Other Study ID Numbers: 202202042DINC
First Posted: October 3, 2022    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases