Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Plasmapheresis
• Interventions: Procedure: Plasmapheresis

• Registration Number: NCT05562960
• Lead Sponsor: National Taiwan University Hospital

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Study Start: 2023-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALS patients receiving plasmapheresis	Plasmapheresis	Plasmapheresis in ALS patients with different titers of autoantibody against NRIP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Change in compound motor action potentials	Before intervention and on day 90	Change in compound motor action potentials before intervention and on day 90
Change in force vital capacity	Before intervention and on day 90	Change in force vital capacity before intervention and on day 90
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
Any adverse effect under plasmapheresis	Within 6 months during and after plasmapheresis	Any adverse effect during and within 6 months after plasmapheresis

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan