Amyotrophic Lateral Sclerosis Clinical Trial
— PALATINOfficial title:
Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
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
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with amyotrophic lateral sclerosis (ALS) at the age more than 20 years and having plasma anti-NRIP autoantibody. 2. Agree to receive plasmapheresis intervention. 3. Agree to participate in the trial and receive serial examinations and follow up. Exclusion Criteria: 1. Patients without plasma anti-NRIP autoantibody. 2. Patients requiring permanent ventilator support for ALS progression. 3. Not able to receive plasmapheresis or trial-related examinations. 4. Under pregnancy. 5. Blood fibrinogen level less than 50 mg/dl. 6. Specific ALS subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in ALSFRS-R decline | Change in ALSFRS-R decline before (3-month) and after (3-month) intervention. Before (3-month) and after (3-month) intervention |
| |
Secondary | 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 | |
Secondary | Changes in ALSFRS-R score | Changes in ALSFRS-R score from day 0 to days 30, 90, and 180 | Day 0 to days 30, 90, and 180 | |
Secondary | Change in force vital capacity | Change in force vital capacity before intervention and on day 90 | Before intervention and on day 90 | |
Secondary | Change in compound motor action potentials | Change in compound motor action potentials before intervention and on day 90 | Before intervention and on day 90 | |
Secondary | Changes in anti-NRIP titer | Changes in anti-NRIP titer from day 0 to days 30, 90, and 180 | Day 0 to days 30, 90, and 180 | |
Secondary | Any adverse effect under plasmapheresis | Any adverse effect during and within 6 months after plasmapheresis | Within 6 months during and after plasmapheresis |
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