CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Immunoabsorption/plasmapheresis procedureprocedure
Likely dose
Not stated in record
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Search/NCT04875949
NCT04875949N/ACompleted

Anti-Cholinergic Receptors Antibodies and Dysautonomia Symptoms Relationships in Pure Autonomic Failure, Amyotrophic Lateral Sclerosis, Postural Orthostatic Tachycardia Syndrome: a Pathophysiology Based Therapeutic New Strategy.

Istituto Clinico Humanitas·interventional·Posted May 6, 2021·Updated May 6, 2021

In Brief

A clinical study evaluating Immunoabsorption/plasmapheresis procedure for Pure Autonomic Failure and 3 related conditions. Completed, enrolled 75 participants across 1 site.

Detailed Summary

Anti alfa-3 and alfa-7 ganglionic cholinergic receptors (anti-AChRs) antibodies (Abs) plasma removal by plasmapheresis (1,2) acutely improved dysautonomia symptoms in case reports with Pure Autonomic Failure (PAF) (3). We shall assess the prevalence of anti-AChRs Ab and the relationship among Ab titer, cardiovascular autonomic profile and symptoms in neurodegenerative diseases characterized by similar dysautonomia symptoms such as PAF, Amyotrophic Lateral Sclerosis (ALS) and Postural Orthostatic Tachycardia Syndrome (POTS) (4). Ab positive patients will undergo selective immunoabsorption once a week up to achievement of Ab titer lower than 65% of baseline followed by immunosuppressive therapy with prednisone. Both Ab positive and negative groups will undergo anti-AChR Abs, autonomic profile and dysautonomia symptoms assessment, every 4 months up to 3 years. Evidence of correlation among reduced Ab titer and autonomic profile and symptoms improvement may result in new effective therapy.

Study Details

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 6, 2021
Enrollment StartApr 1, 2016
Primary CompletionJan 1, 2019
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.2 years ago

Interventions

Immunoabsorption/plasmapheresis procedureprocedure