Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

Amyotrophic Lateral Sclerosis Clinical Trial

— PALATIN  

Official title:

Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562960
• Other study ID #: 202202042DINC
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Plasmapheresis
• Sclerosis

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