Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

NCT ID: NCT05562960

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Amyotrophic Lateral Sclerosis Plasmapheresis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALS patients receiving plasmapheresis

Plasmapheresis in ALS patients with different titers of autoantibody against NRIP

Group Type OTHER

Plasmapheresis

Intervention Type PROCEDURE

Regular plasmapheresis to remove anti-NRIP autoantibody

Interventions

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Plasmapheresis

Regular plasmapheresis to remove anti-NRIP autoantibody

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li-Kai Tsai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Li-Kai Tsai, MD, PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Li-Kai Tsai, MD, PhD

Role: primary

Other Identifiers

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202202042DINC

Identifier Type: -

Identifier Source: org_study_id