Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

National Taiwan University Hospital20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis Plasmapheresis

Interventions

PlasmapheresisPROCEDURE

Regular plasmapheresis to remove anti-NRIP autoantibody

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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\>

Time frame: Before (3-month) and after (3-month) intervention

Secondary Outcomes

Change in ALSFRS-R decline

Change in ALSFRS-R decline before (3-month) and after (6-month) intervention

Time frame: 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

Time frame: Day 0 to days 30, 90, and 180

Change in force vital capacity

Change in force vital capacity before intervention and on day 90

Time frame: Before intervention and on day 90

Change in compound motor action potentials

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

Time frame: 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

Time frame: Day 0 to days 30, 90, and 180

Any adverse effect under plasmapheresis

Any adverse effect during and within 6 months after plasmapheresis

Time frame: Within 6 months during and after plasmapheresis

Central Contacts

Li-Kai Tsai, MD, PhD

CONTACT

886-2-23123456 milikai@ntuh.gov.tw

Data from ClinicalTrials.gov

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