Amyotrophic Lateral Sclerosis (ALS)PALADIN2NCT07726563
Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP 2 (PALADIN2)
A study testing plasmapheresis in people with Amyotrophic Lateral Sclerosis (ALS) and Autoantibody, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
10-20% of patients with ALS have anti-NRIP autoantibody and the titer of anti-NRIP autoantibody is correlated with motor functional decline and mortality in ALS. The PALADIN2 clinical trial is a single arm study, which intends to enroll 20 ALS patients having anti-NRIP autoantibody in plasma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Autoantibody, Plasmapheresis
- What is being tested?
- plasmapheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 May 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ALS patients above 20-year-old who have anti-NRIP autoantibody in plasma
- Agree to receive plasmapheresis treatment
- Agree to participate in the study and receive serial examinations
Who cannot join
- Under permanent ventilator support
- Cannot receive plasmapheresis treatment or serial examinations
- Under pregnancy
- Blood fibrinogen level below 50 mg/dl
- Belong to special subtype of ALS, such as primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, flail leg syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei City, Taipei, 100
Li-Kai Tsai, MD, PhD, 886-2-972651560, milikai@ntuh.gov.tw
milikai@ntuh.gov.tw
About this study
10-20% of patients with ALS have anti-NRIP autoantibody and the titer of anti-NRIP autoantibody is correlated with motor functional decline and mortality in ALS. The PALADIN2 clinical trial is a single arm study, which intends to enroll 20 ALS patients having anti-NRIP autoantibody in plasma. Patients will receive 3 courses of plasmapheresis per 3 months in order to maintain low concentration of anti-NRIP autoantibody in plasma. The study will follow up these patients for another 6 months after plasmapheresis. This project will potentially confirm the efficacy and safety of plasmapheresis for ALS patients having anti-NRIP autoantibody.
- Being tested
- plasmapheresis
- Keywords
- amyotrophic lateral sclerosis, anti-NRIP autoantibody, 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.
plasmapheresisDevice
Using plasmapheresis to remove plasma anti-NRIP autoantibody; each patient receive 3 courses of plasmapheresis with 3 months apart
| Study group | Role | What they receive |
|---|---|---|
| ALS patients with anti-NRIP autoantibody | Experimental | Not described Receives: Device: plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
Difference between [(ALSFRS-R at month -3 - ALSFRS-R at month 0)/3] and [(ALSFRS-R at month 0 - ALSFRS-R at month 9)/9]; Months -3 to 0 vs. Months 0 to 9; the higher above ratio means higher disease progression rate
Measured: 12 months
Secondary outcomes (12)
Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
Difference between [(ALSFRS-R at month -3 - ALSFRS-R at month 0)/3] and [(ALSFRS-R at month 0 - ALSFRS-R at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
Measured: 15 months
Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
Difference between [(ALSFRS-R at month -3 - ALSFRS-R at month 0)/3] and [(ALSFRS-R at month 0 - ALSFRS-R at month 3)/3]; Months -3 to 0 vs. Months 0 to 3; the higher above ratio means higher disease progression rate
Measured: 6 months
Change in disease severity measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
The ALSFRS-R at months 3, 6, 9,12 as compared to that at month 0; the lower the AFSFRS-R, the worse disease severity
Measured: 12 months
Change in disease progression rates measuring using MRC (Medical Research Council score) mega-score
Difference between [(MRC mega-score at month -3 - MRC mega-score at month 0)/3] and [(MRC mega-score at month 0 - MRC mega-score at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
Measured: 15 months
Change in disease progression rates measuring using Grips force (lb)
Description: Difference between [(Grips force at month -3 - Grips force at month 0)/3] and [(Grips force at month 0 - Grips force at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
Measured: 15 months
Change in disease progression rates measuring using 6MWT (6 minute walking test); distance in meters
Difference between [(distance at month -3 - distance at month 0)/3] and [(distance at month 0 - distance at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio, the higher disease progression rate
Measured: 15 months
Change in disease progression rates measuring using EQ-5D (EuroQol Group Life Quality Score)
Difference between [(Score at month -3 - Score at month 0)/3] and [(Score at month 0 - Score at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
Measured: 15 months
Change in disease progression rates measuring using respiratory vital capacity (standardized vital capacity, %)
Difference between [(vital capacity -3 - vital capacity at month 0)/3] and [(vital capacity at month 0 - vital capacity at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
Measured: 15 months
Change in disease progression rates measuring using CMAP (compound muscle action potential, mV)
Difference between [(CMAP -3 - CMAP at month 0)/3] and [(CMAP at month 0 - CMAP at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
Measured: 15 months
Change in disease progression rates measuring using MUNE (motor unit number estimation; number)
Difference between [(MUNE -3 - MUNE at month 0)/3] and [(MUNE at month 0 - MUNE at month 12)/12]; Months -3 to 0 vs. Months 0 to 12; the higher above ratio means higher disease progression rate
Measured: 15 months
Change in disease severity measuring using plasma NF-L (Neurofilament-light chain; pg/mL)
The NF-L at months 3, 6, 9,12 as compared to that at month 0; the lower the NF-L, the milder disease activity
Measured: 12 months
Any side effect under plasmapheresis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start19 May 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726563
- Sponsor's protocol ID
- 202502154DINB
- Acronym
- PALADIN2
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tsai LK, Chen IH, Chao CC, Hsueh HW, Chen HH, Huang YH, Weng RW, Lai TY, Tsai YC, Tsao YP, Chen SL. Autoantibody of NRIP, a novel AChR-interacting protein, plays a detrimental role in myasthenia gravis. J Cachexia Sarcopenia Muscle. 2021 Jun;12(3):665-676. doi: 10.1002/jcsm.12697. Epub 2021 Mar 26.
PubMed 33773096
Study at a glance
From the registry record, last updated by the sponsor on 24 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 2 (PALADIN2)
- ClinicalTrials.gov ID
- NCT07726563
- Acronym / sponsor ID
- PALADIN2 / 202502154DINB
- Keywords
- amyotrophic lateral sclerosis, anti-NRIP autoantibody, plasmapheresis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 24 Jul 2026 (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.
10-20% of patients with ALS have anti-NRIP autoantibody and the titer of anti-NRIP autoantibody is correlated with motor functional decline and mortality in ALS. The PALADIN2 clinical trial is a single arm study, which intends to enroll 20 ALS patients having anti-NRIP autoantibody in plasma. Patients will receive 3 courses of plasmapheresis per 3 months in order to maintain low concentration of anti-NRIP autoantibody in plasma. The study will follow up these patients for another 6 months after plasmapheresis. This project will potentially confirm the efficacy and safety of plasmapheresis for ALS patients having 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 with anti-NRIP autoantibody | Experimental | Device: plasmapheresis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ALS patients above 20-year-old who have anti-NRIP autoantibody in plasma
- Agree to receive plasmapheresis treatment
- Agree to participate in the study and receive serial examinations
Key exclusion criteria (5 listed)
- Under permanent ventilator support
- Cannot receive plasmapheresis treatment or serial examinations
- Under pregnancy
- Blood fibrinogen level below 50 mg/dl
- Belong to special subtype of ALS, such as primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, flail leg syndrome.
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 |
|---|---|---|
| plasmapheresisUsing plasmapheresis to remove plasma anti-NRIP autoantibody; each patient receive 3 courses of plasmapheresis with 3 months apart | Device | ALS patients with anti-NRIP autoantibody |
Primary outcome
Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
Time frame: 12 months
Difference between [(ALSFRS-R at month -3 - ALSFRS-R at month 0)/3] and [(ALSFRS-R at month 0 - ALSFRS-R at month 9)/9]; Months -3 to 0 vs. Months 0 to 9; the higher above ratio means higher disease progression rate
12 secondary outcomes
Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
Time frame: 15 months
Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
Time frame: 6 months
Change in disease severity measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised)
Time frame: 12 months
Change in disease progression rates measuring using MRC (Medical Research Council score) mega-score
Time frame: 15 months
Change in disease progression rates measuring using Grips force (lb)
Time frame: 15 months
Change in disease progression rates measuring using 6MWT (6 minute walking test); distance in meters
Time frame: 15 months
Change in disease progression rates measuring using EQ-5D (EuroQol Group Life Quality Score)
Time frame: 15 months
Change in disease progression rates measuring using respiratory vital capacity (standardized vital capacity, %)
Time frame: 15 months
Change in disease progression rates measuring using CMAP (compound muscle action potential, mV)
Time frame: 15 months
Change in disease progression rates measuring using MUNE (motor unit number estimation; number)
Time frame: 15 months
Change in disease severity measuring using plasma NF-L (Neurofilament-light chain; pg/mL)
Time frame: 12 months
Any side effect under plasmapheresis
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 33773096Tsai LK, Chen IH, Chao CC, Hsueh HW, Chen HH, Huang YH, Weng RW, Lai TY, Tsai YC, Tsao YP, Chen SL. Autoantibody of NRIP, a novel AChR-interacting protein, plays a detrimental role in myasthenia gravis. J Cachexia Sarcopenia Muscle. 2021 Jun;12(3):665-676. doi: 10.1002/jcsm.12697. Epub 2021 Mar 26.
- Individual participant dataSharing planned: Yes
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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.
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 (ALS) and Autoantibody, 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 5 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: looking for participants now, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Kai Tsai, MD, PhD (+886972651560, milikai@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726563, which also lists 1 linked publication.
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 24 Jul 2026.