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Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP 2 (PALADIN2)

ConditionsAmyotrophic Lateral Sclerosis (ALS)AutoantibodyPlasmapheresis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Under permanent ventilator support

Cannot receive plasmapheresis treatment or serial examinations

Under pregnancy

Blood fibrinogen level below 50 mg/dl

Trial design

Design model

Single group

Treatments tested in this trial

  • plasmapheresis

    Device

    Using plasmapheresis to remove plasma anti-NRIP autoantibody; each patient receive 3 courses of plasmapheresis with 3 months apart

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: ALS patients with anti-NRIP autoantibodyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
15 months
2

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

Time frame
6 months
3

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

Time frame
12 months
4

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

Time frame
15 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

National Taiwan University HospitalRecruiting100, Taipei City, TaipeiTaiwanTaiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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