Plasmapheresis in Amyotrophic Lateral Sclerosis With Auto... | NCT05562960

Studies
Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP

NCT05562960

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Dec 18, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Amyotrophic Lateral Sclerosis
Plasmapheresis

Interventions

Plasmapheresis

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Sep 28, 2022

First Submission Date that Met QC Criteria

Sep 28, 2022

First Posted Date

Oct 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2024

Last Update Posted Date

Dec 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALS patients receiving plasmapheresis	Other	Plasmapheresis in ALS patients with different titers of autoantibody against NRIP	Procedure: Plasmapheresis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasmapheresis	Procedure	Regular plasmapheresis to remove anti-NRIP autoantibody	ALS patients receiving plasmapheresis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Changes in ALSFRS-R score	Changes in ALSFRS-R score from day 0 to days 30, 90, and 180

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li-Kai Tsai, MD, PhD	Contact	886-2-23123456	63476	milikai@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Li-Kai Tsai, MD, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010956	Plasmapheresis

Ancestor Terms

ID	Term
D001781	Blood Component Removal
D013812	Therapeutics
D016060	Sorption Detoxification
D005112	Extracorporeal Circulation

Browse Leaves

Not provided

Browse Branches

Not provided