Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
PALATIN
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedDecember 18, 2024
December 1, 2024
1.9 years
September 28, 2022
December 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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\>
Before (3-month) and after (3-month) intervention
Secondary Outcomes (6)
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
Change in force vital capacity
Before intervention and on day 90
Change in compound motor action potentials
Before intervention and on day 90
Changes in anti-NRIP titer
Day 0 to days 30, 90, and 180
- +1 more secondary outcomes
Study Arms (1)
ALS patients receiving plasmapheresis
OTHERPlasmapheresis in ALS patients with different titers of autoantibody against NRIP
Interventions
Regular plasmapheresis to remove anti-NRIP autoantibody
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Kai Tsai, MD, PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2022
First Posted
October 3, 2022
Study Start
May 1, 2023
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
December 18, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share