Pure Autonomic FailureDISAUT-ABNCT04875949
Anti-Cholinergic Receptors Antibodies, Autonomic Profile and Dysautonomia Symptoms in PAF, ALS and POTS (DISAUT-AB)
A study testing Immunoabsorption/plasmapheresis procedure in people with Pure Autonomic Failure and Amyotrophic Lateral Sclerosis, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pure Autonomic Failure, Amyotrophic Lateral Sclerosis, Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Immunoabsorption/plasmapheresis procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
PAF is a rare neurodegenerative disorder characterized by symptoms due to sympathetic failure, such as orthostatic hypotension and syncope, and deficient parasympathetic activity such as constipation, urinary retention and decreased salivation (3). Plasma anti-AChRs Abs were found in PAF (1, 2, 5) and in POTS (6), raising the possibility that Ab mediated alterations in the ganglionic cholinergic function might induce autonomic abnormalities and related symptoms. Anti-AchRs Abs removal by plasmapheresis was associated with acute improvement of orthostatic tolerance in PAF single case report (2).
There is no data on the medium/long term clinical follow-up of these patients. Nothing is known about the time course of the relationships among Abs plasma titer, neural autonomic profile and symptoms if a selective immunoabsorption procedure is combined with drug immunosoppression (Prednisone) to lower Ab levels and potentially ameliorate ganglionic function.
Finally, it is unknown whether a neurodegenerative disease with concomitant dysautonomia symptoms such as the Amyotrophic Lateral Sclerosis (ALS) may share an analogous anti-AChRs Ab profile. Variations in cholinergic receptor subunits 3 and 4 were observed in ALS but no plasma anti-AChRs Abs were searched for (7). Abs removal by immunoabsorption technique combined with drug immunosoppression might represent a new effective therapy for dysautonomia symptoms in ALS as well as in POTS and PAF.
Hyphotesis and Significance:
- Changes in anti-AChR Abs plasma titer may be mirrored by modifications in the cardiovascular autonomic profile, as assessed by spectrum analysis of RR and arterial pressure variability, and be related to fluctuations in the magnitude of dysautonomia symptoms in PAF, ALS and POTS patients.
- Plasma anti-AChR Abs might underlie dysautonomia symptoms associated to neurodegenerative disorders such as ASL and POTS
- Plasma anti-AChR Abs removal by selective immunoabsorption techniques may improve ganglionic transmission leading to clinical amelioration and represent a new effective etiologic therapy for these diseases.
Specific Aim:
Aim 1: To evaluate the prevalence of plasma anti-AChR Abs in patients affected by PAF, ALS and POTS .
Aim 2: To address the time course and relationships of anti-AChR Abs plasma titers, cardiovascular autonomic profile and dysautonomia symptoms before and after anti-AChR Abs plasma removal by selective immunoabsorption technique in PAF, ALS and POTS patients. The core laboratory of the Neuroimmunology Unit of Istituto Neurologico Besta will provide expertise and facilities for assessing plasma anti-AChR Abs. The clinical laboratory of Clinica Medica Syncope Unit (Humanitas) will provide the know-how and facilities for patients neural autonomic assessment.
Aim 3:To set up a new therapeutic strategy based on selective immunoabsorption technique sessions combined with drug immunosuppression (Prednisone) in patients with anti-AChR Abs.
- Conditions
- Pure Autonomic Failure, Amyotrophic Lateral Sclerosis, Postural Orthostatic Tachycardia Syndrome, Anti-Cholinergic Receptors Antibodies
- Being tested
- Immunoabsorption/plasmapheresis procedure
- Keywords
- Neural control of circulation and respiration, Anti-Cholinergic receptors antibodies, Power Spectrum Analysis
- Medical subject headings
- Pure Autonomic Failure, Amyotrophic Lateral Sclerosis, Postural Orthostatic Tachycardia Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoabsorption/plasmapheresis procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anti-AChRs Abs positive patients | Experimental | Immunoabsorption Receives: Procedure: Immunoabsorption/plasmapheresis procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of plasma anti-AChR Abs in PAF, ALS and POTS
Number of patients with plasma anti-AChR Abs
Measured: 3 years
Effects of anti-AChR Abs removal on dysautonomic symptoms
COMPASS31 scores (range 0-100; 0 best -100 worst)
Measured: 3 years
Time course of dysautonomia symptoms
COMPASS31 scores (range: 0-100; 0 best-100 worst)
Measured: 3 years
Time course of orthostatic tolerance
Orthostatic tolerance (minutes)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study startApr 2016
- Primary completionJan 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pure Autonomic FailureStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Salvatore Maugeri
- Responsible party
- Sponsor
- Investigators
- Raffaello Furlan, Prof., Principal investigator, Humanitas Research Hospital, Humanitas UniversityFranca Barbic, MD, Study chair, Humanitas Research Hospital, Humanitas University, RozzanoRaffaello Furlan, Prof., Study director, Humanitas Research Hospital, Humanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875949
- Sponsor's protocol ID
- DISAUT-AB ICH
- Acronym
- DISAUT-AB
- Status last verified
- May 2021
- First submitted
- 12 Jan 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Vernino S, Low PA, Fealey RD, Stewart JD, Farrugia G, Lennon VA. Autoantibodies to ganglionic acetylcholine receptors in autoimmune autonomic neuropathies. N Engl J Med. 2000 Sep 21;343(12):847-55. doi: 10.1056/NEJM200009213431204.
PubMed 10995864Schroeder C, Vernino S, Birkenfeld AL, Tank J, Heusser K, Lipp A, Benter T, Lindschau C, Kettritz R, Luft FC, Jordan J. Plasma exchange for primary autoimmune autonomic failure. N Engl J Med. 2005 Oct 13;353(15):1585-90. doi: 10.1056/NEJMoa051719.
PubMed 16221781Furlan R, Jacob G, Snell M, Robertson D, Porta A, Harris P, Mosqueda-Garcia R; New Collective Author. Chronic orthostatic intolerance: a disorder with discordant cardiac and vascular sympathetic control. Circulation. 1998 Nov 17;98(20):2154-9. doi: 10.1161/01.cir.98.20.2154.
PubMed 9815870Vernino S, Hopkins S, Wang Z. Autonomic ganglia, acetylcholine receptor antibodies, and autoimmune ganglionopathy. Auton Neurosci. 2009 Mar 12;146(1-2):3-7. doi: 10.1016/j.autneu.2008.09.005. Epub 2008 Oct 31.
PubMed 18951069Sabatelli M, Eusebi F, Al-Chalabi A, Conte A, Madia F, Luigetti M, Mancuso I, Limatola C, Trettel F, Sobrero F, Di Angelantonio S, Grassi F, Di Castro A, Moriconi C, Fucile S, Lattante S, Marangi G, Murdolo M, Orteschi D, Del Grande A, Tonali P, Neri G, Zollino M. Rare missense variants of neuronal nicotinic acetylcholine receptor altering receptor function are associated with sporadic amyotrophic lateral sclerosis. Hum Mol Genet. 2009 Oct 15;18(20):3997-4006. doi: 10.1093/hmg/ddp339. Epub 2009 Jul 23.
PubMed 19628475Vernino S, Adamski J, Kryzer TJ, Fealey RD, Lennon VA. Neuronal nicotinic ACh receptor antibody in subacute autonomic neuropathy and cancer-related syndromes. Neurology. 1998 Jun;50(6):1806-13. doi: 10.1212/wnl.50.6.1806.
PubMed 9633732Furlan R, Piazza S, Bevilacqua M, Turiel M, Norbiato G, Lombardi F, Malliani A. Pure Autonomic Failure: complex abnormalities in the neural mechanisms regulating the cardiovascular system. J Auton Nerv Syst. 1995 Mar 2;51(3):223-35. doi: 10.1016/0165-1838(94)00135-7.
PubMed 7769156Barbic F, Perego F, Canesi M, Gianni M, Biagiotti S, Costantino G, Pezzoli G, Porta A, Malliani A, Furlan R. Early abnormalities of vascular and cardiac autonomic control in Parkinson's disease without orthostatic hypotension. Hypertension. 2007 Jan;49(1):120-6. doi: 10.1161/01.HYP.0000250939.71343.7c. Epub 2006 Nov 13.
PubMed 17101845Porta A, Castiglioni P, Di Rienzo M, Bari V, Bassani T, Marchi A, Takahashi AC, Tobaldini E, Montano N, Catai AM, Barbic F, Furlan R, Cividjian A, Quintin L. Short-term complexity indexes of heart period and systolic arterial pressure variabilities provide complementary information. J Appl Physiol (1985). 2012 Dec 15;113(12):1810-20. doi: 10.1152/japplphysiol.00755.2012. Epub 2012 Oct 25.
PubMed 23104699Furlan R, Porta A, Costa F, Tank J, Baker L, Schiavi R, Robertson D, Malliani A, Mosqueda-Garcia R; New Collective Author. Oscillatory patterns in sympathetic neural discharge and cardiovascular variables during orthostatic stimulus. Circulation. 2000 Feb 29;101(8):886-92. doi: 10.1161/01.cir.101.8.886.
PubMed 10694528Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16.
PubMed 24436294Low PA. Composite autonomic scoring scale for laboratory quantification of generalized autonomic failure. Mayo Clin Proc. 1993 Aug;68(8):748-52. doi: 10.1016/s0025-6196(12)60631-4.
PubMed 8392653Chio A, Mora G, Restagno G, Brunetti M, Ossola I, Barberis M, Ferrucci L, Canosa A, Manera U, Moglia C, Fuda G, Traynor BJ, Calvo A. UNC13A influences survival in Italian amyotrophic lateral sclerosis patients: a population-based study. Neurobiol Aging. 2013 Jan;34(1):357.e1-5. doi: 10.1016/j.neurobiolaging.2012.07.016. Epub 2012 Aug 22.
PubMed 22921269Chio A, Calvo A, Moglia C, Mazzini L, Mora G; PARALS study group. Phenotypic heterogeneity of amyotrophic lateral sclerosis: a population based study. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):740-6. doi: 10.1136/jnnp.2010.235952. Epub 2011 Mar 14.
PubMed 21402743
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04875949
- Acronym / sponsor ID
- DISAUT-AB / DISAUT-AB ICH
- Conditions
- Pure Autonomic Failure, Amyotrophic Lateral Sclerosis, Postural Orthostatic Tachycardia Syndrome, Anti-Cholinergic Receptors Antibodies
- Keywords
- Neural control of circulation and respiration, Anti-Cholinergic receptors antibodies, Power Spectrum Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione Salvatore Maugeri
- Study start
- Apr 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PAF is a rare neurodegenerative disorder characterized by symptoms due to sympathetic failure, such as orthostatic hypotension and syncope, and deficient parasympathetic activity such as constipation, urinary retention and decreased salivation (3). Plasma anti-AChRs Abs were found in PAF (1, 2, 5) and in POTS (6), raising the possibility that Ab mediated alterations in the ganglionic cholinergic function might induce autonomic abnormalities and related symptoms. Anti-AchRs Abs removal by plasmapheresis was associated with acute improvement of orthostatic tolerance in PAF single case report (2).
There is no data on the medium/long term clinical follow-up of these patients. Nothing is known about the time course of the relationships among Abs plasma titer, neural autonomic profile and symptoms if a selective immunoabsorption procedure is combined with drug immunosoppression (Prednisone) to lower Ab levels and potentially ameliorate ganglionic function.
Finally, it is unknown whether a neurodegenerative disease with concomitant dysautonomia symptoms such as the Amyotrophic Lateral Sclerosis (ALS) may share an analogous anti-AChRs Ab profile. Variations in cholinergic receptor subunits 3 and 4 were observed in ALS but no plasma anti-AChRs Abs were searched for (7). Abs removal by immunoabsorption technique combined with drug immunosoppression might represent a new effective therapy for dysautonomia symptoms in ALS as well as in POTS and PAF.
Hyphotesis and Significance:
- Changes in anti-AChR Abs plasma titer may be mirrored by modifications in the cardiovascular autonomic profile, as assessed by spectrum analysis of RR and arterial pressure variability, and be related to fluctuations in the magnitude of dysautonomia symptoms in PAF, ALS and POTS patients.
- Plasma anti-AChR Abs might underlie dysautonomia symptoms associated to neurodegenerative disorders such as ASL and POTS
- Plasma anti-AChR Abs removal by selective immunoabsorption techniques may improve ganglionic transmission leading to clinical amelioration and represent a new effective etiologic therapy for these diseases.
Specific Aim:
Aim 1: To evaluate the prevalence of plasma anti-AChR Abs in patients affected by PAF, ALS and POTS .
Aim 2: To address the time course and relationships of anti-AChR Abs plasma titers, cardiovascular autonomic profile and dysautonomia symptoms before and after anti-AChR Abs plasma removal by selective immunoabsorption technique in PAF, ALS and POTS patients. The core laboratory of the Neuroimmunology Unit of Istituto Neurologico Besta will provide expertise and facilities for assessing plasma anti-AChR Abs. The clinical laboratory of Clinica Medica Syncope Unit (Humanitas) will provide the know-how and facilities for patients neural autonomic assessment.
Aim 3:To set up a new therapeutic strategy based on selective immunoabsorption technique sessions combined with drug immunosuppression (Prednisone) in patients with anti-AChR Abs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-AChRs Abs positive patients | Experimental | Procedure: Immunoabsorption/plasmapheresis procedureImmunoabsorption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoabsorption/plasmapheresis procedure | Procedure or surgery | Anti-AChRs Abs positive patients |
Primary outcome
Prevalence of plasma anti-AChR Abs in PAF, ALS and POTS
Time frame: 3 years
Number of patients with plasma anti-AChR Abs
Effects of anti-AChR Abs removal on dysautonomic symptoms
Time frame: 3 years
COMPASS31 scores (range 0-100; 0 best -100 worst)
Time course of dysautonomia symptoms
Time frame: 3 years
COMPASS31 scores (range: 0-100; 0 best-100 worst)
Time course of orthostatic tolerance
Time frame: 3 years
Orthostatic tolerance (minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 10995864Vernino S, Low PA, Fealey RD, Stewart JD, Farrugia G, Lennon VA. Autoantibodies to ganglionic acetylcholine receptors in autoimmune autonomic neuropathies. N Engl J Med. 2000 Sep 21;343(12):847-55. doi: 10.1056/NEJM200009213431204.
- Background: PubMed 16221781Schroeder C, Vernino S, Birkenfeld AL, Tank J, Heusser K, Lipp A, Benter T, Lindschau C, Kettritz R, Luft FC, Jordan J. Plasma exchange for primary autoimmune autonomic failure. N Engl J Med. 2005 Oct 13;353(15):1585-90. doi: 10.1056/NEJMoa051719.
- Background: PubMed 9815870Furlan R, Jacob G, Snell M, Robertson D, Porta A, Harris P, Mosqueda-Garcia R; New Collective Author. Chronic orthostatic intolerance: a disorder with discordant cardiac and vascular sympathetic control. Circulation. 1998 Nov 17;98(20):2154-9. doi: 10.1161/01.cir.98.20.2154.
- Background: PubMed 18951069Vernino S, Hopkins S, Wang Z. Autonomic ganglia, acetylcholine receptor antibodies, and autoimmune ganglionopathy. Auton Neurosci. 2009 Mar 12;146(1-2):3-7. doi: 10.1016/j.autneu.2008.09.005. Epub 2008 Oct 31.
- Background: PubMed 19628475Sabatelli M, Eusebi F, Al-Chalabi A, Conte A, Madia F, Luigetti M, Mancuso I, Limatola C, Trettel F, Sobrero F, Di Angelantonio S, Grassi F, Di Castro A, Moriconi C, Fucile S, Lattante S, Marangi G, Murdolo M, Orteschi D, Del Grande A, Tonali P, Neri G, Zollino M. Rare missense variants of neuronal nicotinic acetylcholine receptor altering receptor function are associated with sporadic amyotrophic lateral sclerosis. Hum Mol Genet. 2009 Oct 15;18(20):3997-4006. doi: 10.1093/hmg/ddp339. Epub 2009 Jul 23.
- Background: PubMed 9633732Vernino S, Adamski J, Kryzer TJ, Fealey RD, Lennon VA. Neuronal nicotinic ACh receptor antibody in subacute autonomic neuropathy and cancer-related syndromes. Neurology. 1998 Jun;50(6):1806-13. doi: 10.1212/wnl.50.6.1806.
- Background: PubMed 7769156Furlan R, Piazza S, Bevilacqua M, Turiel M, Norbiato G, Lombardi F, Malliani A. Pure Autonomic Failure: complex abnormalities in the neural mechanisms regulating the cardiovascular system. J Auton Nerv Syst. 1995 Mar 2;51(3):223-35. doi: 10.1016/0165-1838(94)00135-7.
- Background: PubMed 17101845Barbic F, Perego F, Canesi M, Gianni M, Biagiotti S, Costantino G, Pezzoli G, Porta A, Malliani A, Furlan R. Early abnormalities of vascular and cardiac autonomic control in Parkinson's disease without orthostatic hypotension. Hypertension. 2007 Jan;49(1):120-6. doi: 10.1161/01.HYP.0000250939.71343.7c. Epub 2006 Nov 13.
- Background: PubMed 23104699Porta A, Castiglioni P, Di Rienzo M, Bari V, Bassani T, Marchi A, Takahashi AC, Tobaldini E, Montano N, Catai AM, Barbic F, Furlan R, Cividjian A, Quintin L. Short-term complexity indexes of heart period and systolic arterial pressure variabilities provide complementary information. J Appl Physiol (1985). 2012 Dec 15;113(12):1810-20. doi: 10.1152/japplphysiol.00755.2012. Epub 2012 Oct 25.
- Background: PubMed 10694528Furlan R, Porta A, Costa F, Tank J, Baker L, Schiavi R, Robertson D, Malliani A, Mosqueda-Garcia R; New Collective Author. Oscillatory patterns in sympathetic neural discharge and cardiovascular variables during orthostatic stimulus. Circulation. 2000 Feb 29;101(8):886-92. doi: 10.1161/01.cir.101.8.886.
- Background: PubMed 24436294Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16.
- Background: PubMed 8392653Low PA. Composite autonomic scoring scale for laboratory quantification of generalized autonomic failure. Mayo Clin Proc. 1993 Aug;68(8):748-52. doi: 10.1016/s0025-6196(12)60631-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaello Furlan, Prof. principal investigator
Humanitas Research Hospital, Humanitas University
Franca Barbic, MD study chair
Humanitas Research Hospital, Humanitas University, Rozzano
Raffaello Furlan, Prof. study director
Humanitas Research Hospital, Humanitas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunoabsorption/plasmapheresis procedure in people with Pure Autonomic Failure and Amyotrophic Lateral Sclerosis, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of plasma anti-AChR Abs in PAF, ALS and POTS (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04875949, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.