Amyotrophic Lateral Sclerosis Clinical Trial
— DISAUT-ABOfficial title:
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.
NCT number | NCT04875949 |
Other study ID # | DISAUT-AB ICH |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | April 2019 |
Verified date | May 2021 |
Source | Istituto Clinico Humanitas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | April 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: • Patients, older than 18 years affected by PAF, ALS and POTS, with dysautonomia symptoms assessed by clinical evaluation and by the Composite Autonomic Scoring Scale (CASS) Exclusion Criteria: - Hepatic, renal, heart and other secondary causes of autonomic dysfunction - History/familiarity with seizures - Atrial fibrillation and other relevant cardiac rhythm disturbances - Diabetes - Other neurological or psychiatric diseases - Pacemakers or other electronic implants inserted into the body - Coronary disorders, elevated intracranial blood pressure - Assumption of drugs facilitating seizures, psychiatric drugs, alcohol abuse |
Country | Name | City | State |
---|---|---|---|
Italy | Humanitas Research Hospital | Rozzano |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Salvatore Maugeri |
Italy,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of plasma anti-AChR Abs in PAF, ALS and POTS | Number of patients with plasma anti-AChR Abs | 3 years | |
Primary | Effects of anti-AChR Abs removal on dysautonomic symptoms | COMPASS31 scores (range 0-100; 0 best -100 worst) | 3 years | |
Primary | Time course of dysautonomia symptoms | COMPASS31 scores (range: 0-100; 0 best-100 worst) | 3 years | |
Primary | Time course of orthostatic tolerance | Orthostatic tolerance (minutes) | 3 years |
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