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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05562960
Other study ID # 202202042DINC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date March 31, 2025

Study information

Verified date November 2023
Source National Taiwan University Hospital
Contact Li-Kai Tsai, MD, PhD
Phone 886-2-23123456
Email milikai@ntuh.gov.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Plasmapheresis
Regular plasmapheresis to remove anti-NRIP autoantibody

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ALSFRS-R decline Change in ALSFRS-R decline before (3-month) and after (3-month) intervention. Before (3-month) and after (3-month) intervention
Secondary Change in ALSFRS-R decline Change in ALSFRS-R decline before (3-month) and after (6-month) intervention Before (3-month) and after (6-month) intervention
Secondary Changes in ALSFRS-R score Changes in ALSFRS-R score from day 0 to days 30, 90, and 180 Day 0 to days 30, 90, and 180
Secondary Change in force vital capacity Change in force vital capacity before intervention and on day 90 Before intervention and on day 90
Secondary Change in compound motor action potentials Change in compound motor action potentials before intervention and on day 90 Before intervention and on day 90
Secondary Changes in anti-NRIP titer Changes in anti-NRIP titer from day 0 to days 30, 90, and 180 Day 0 to days 30, 90, and 180
Secondary Any adverse effect under plasmapheresis Any adverse effect during and within 6 months after plasmapheresis Within 6 months during and after plasmapheresis
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