Amyotrophic Lateral SclerosisPALATINNCT05562960
Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
A study testing Plasmapheresis in people with Amyotrophic Lateral Sclerosis and Plasmapheresis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Plasmapheresis
- What is being tested?
- Plasmapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Amyotrophic Lateral Sclerosis, Plasmapheresis
- Being tested
- Plasmapheresis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmapheresisProcedure or surgery
Regular plasmapheresis to remove anti-NRIP autoantibody
| Study group | Role | What they receive |
|---|---|---|
| ALS patients receiving plasmapheresis | Other | Plasmapheresis in ALS patients with different titers of autoantibody against NRIP Receives: Procedure: Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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>
Measured: Before (3-month) and after (3-month) intervention
Secondary outcomes (6)
Change in ALSFRS-R decline
Change in ALSFRS-R decline before (3-month) and after (6-month) intervention
Measured: 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
Measured: Day 0 to days 30, 90, and 180
Change in force vital capacity
Change in force vital capacity before intervention and on day 90
Measured: Before intervention and on day 90
Change in compound motor action potentials
Change in compound motor action potentials before intervention and on day 90
Measured: 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
Measured: Day 0 to days 30, 90, and 180
Any adverse effect under plasmapheresis
Any adverse effect during and within 6 months after plasmapheresis
Measured: Within 6 months during and after plasmapheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 May 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Kai Tsai, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562960
- Sponsor's protocol ID
- 202202042DINC
- Acronym
- PALATIN
- Status last verified
- Feb 2026
- First submitted
- 28 Sep 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
- ClinicalTrials.gov ID
- NCT05562960
- Acronym / sponsor ID
- PALATIN / 202202042DINC
- Conditions
- Amyotrophic Lateral Sclerosis, Plasmapheresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS patients receiving plasmapheresis | Other | Procedure: PlasmapheresisPlasmapheresis in ALS patients with different titers of autoantibody against NRIP |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmapheresisRegular plasmapheresis to remove anti-NRIP autoantibody | Procedure or surgery | ALS patients receiving plasmapheresis |
Primary outcome
Change in ALSFRS-R decline
Time frame: Before (3-month) and after (3-month) intervention
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>
6 secondary outcomes
Change in ALSFRS-R decline
Time frame: Before (3-month) and after (6-month) intervention
Changes in ALSFRS-R score
Time frame: Day 0 to days 30, 90, and 180
Change in force vital capacity
Time frame: Before intervention and on day 90
Change in compound motor action potentials
Time frame: Before intervention and on day 90
Changes in anti-NRIP titer
Time frame: Day 0 to days 30, 90, and 180
Any adverse effect under plasmapheresis
Time frame: Within 6 months during and after plasmapheresis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Kai Tsai, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmapheresis in people with Amyotrophic Lateral Sclerosis and Plasmapheresis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ALSFRS-R decline (time frame: Before (3-month) and after (3-month) intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.