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

Primary Purpose

Amyotrophic Lateral Sclerosis, Plasmapheresis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plasmapheresis
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    ALS patients receiving plasmapheresis

    Arm Description

    Plasmapheresis in ALS patients with different titers of autoantibody against NRIP

    Outcomes

    Primary Outcome Measures

    Change in ALSFRS-R decline
    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

    Change in ALSFRS-R decline
    Change in ALSFRS-R decline before (3-month) and after (6-month) intervention
    Changes in ALSFRS-R score
    Changes in ALSFRS-R score from day 0 to days 30, 90, and 180
    Change in force vital capacity
    Change in force vital capacity before intervention and on day 90
    Change in compound motor action potentials
    Change in compound motor action potentials before intervention and on day 90
    Changes in anti-NRIP titer
    Changes in anti-NRIP titer from day 0 to days 30, 90, and 180
    Any adverse effect under plasmapheresis
    Any adverse effect during and within 6 months after plasmapheresis

    Full Information

    First Posted
    September 28, 2022
    Last Updated
    October 3, 2022
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05562960
    Brief Title
    Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
    Acronym
    PALATIN
    Official Title
    Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    March 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amyotrophic Lateral Sclerosis, Plasmapheresis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ALS patients receiving plasmapheresis
    Arm Type
    Other
    Arm Description
    Plasmapheresis in ALS patients with different titers of autoantibody against NRIP
    Intervention Type
    Procedure
    Intervention Name(s)
    Plasmapheresis
    Intervention Description
    Regular plasmapheresis to remove anti-NRIP autoantibody
    Primary Outcome Measure Information:
    Title
    Change in ALSFRS-R decline
    Description
    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>
    Time Frame
    Before (3-month) and after (3-month) intervention
    Secondary Outcome Measure Information:
    Title
    Change in ALSFRS-R decline
    Description
    Change in ALSFRS-R decline before (3-month) and after (6-month) intervention
    Time Frame
    Before (3-month) and after (6-month) intervention
    Title
    Changes in ALSFRS-R score
    Description
    Changes in ALSFRS-R score from day 0 to days 30, 90, and 180
    Time Frame
    Day 0 to days 30, 90, and 180
    Title
    Change in force vital capacity
    Description
    Change in force vital capacity before intervention and on day 90
    Time Frame
    Before intervention and on day 90
    Title
    Change in compound motor action potentials
    Description
    Change in compound motor action potentials before intervention and on day 90
    Time Frame
    Before intervention and on day 90
    Title
    Changes in anti-NRIP titer
    Description
    Changes in anti-NRIP titer from day 0 to days 30, 90, and 180
    Time Frame
    Day 0 to days 30, 90, and 180
    Title
    Any adverse effect under plasmapheresis
    Description
    Any adverse effect during and within 6 months after plasmapheresis
    Time Frame
    Within 6 months during and after plasmapheresis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li-Kai Tsai, MD., Ph.D.
    Phone
    886-2-23123456
    Ext
    63476
    Email
    milikai@ntuh.gov.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

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