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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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. 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

Primary outcome measure(s)

• Change in disease progression rates measuring using ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) — 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

Trial sites (1)

More National Taiwan University Hospital trials in Taiwan

Other trials for the same condition