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PALATIN: Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05562960
Collaborator
(none)
20
Enrollment
1
Arm
28.9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Plasmapheresis
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. Change in ALSFRS-R decline [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 [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 [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 [Before intervention and on day 90]

    Change in force vital capacity before intervention and on day 90

  4. Change in compound motor action potentials [Before intervention and on day 90]

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

  5. Changes in anti-NRIP titer [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 [Within 6 months during and after plasmapheresis]

    Any adverse effect during and within 6 months after plasmapheresis

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05562960
Other Study ID Numbers:
  • 202202042DINC
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 5, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis

Study Results

No Results Posted as of Oct 5, 2022