PoliomyelitisNCT00001185
Study of "Post-Polio Syndrome"
An observational study of Poliomyelitis and Postpoliomyelitis Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Polio or poliomyelitis is the disease caused by the poliovirus. The virus attacks cells in the spinal cord and causes symptoms of fever, sore throat, headache, vomiting, and stiffness of the neck. Patients with polio can have long-term weakness of muscles as a result of the damaged cells in the spinal cord. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Poliomyelitis, Postpoliomyelitis Syndrome
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1982to May 2003
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with prior history of a well documented acute paralytic poliomyelitis with or without development of new neuromuscular symptoms after a minimum of 15 years from the acute illness will be studied.
- Patients will be screened in the outpatient clinic and will be studied as inpatients (or, if stable, as outpatients) for three day stay.
- Severly disabled patients with unstable respiratory function or those who require intensive care nursing or respiratory assistance will be excluded from the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Post-Polio Motor Neuron Disease: Clinical, Virological, and Immunological Studies
Polio or poliomyelitis is the disease caused by the poliovirus. The virus attacks cells in the spinal cord and causes symptoms of fever, sore throat, headache, vomiting, and stiffness of the neck. Patients with polio can have long-term weakness of muscles as a result of the damaged cells in the spinal cord. Occasionally, patients that recover from the disease can experience a relapse of muscle weakness. This can occur as long as 25-35 years after first having polio. The condition is called "post-polio syndrome".
Not all nerve cells in the spinal cord are damaged by the poliovirus. Some nerve cells remain healthy and take over the work of the damaged cells. Researchers believe that the "post-polio syndrome" may be caused by failure of these overworked nerve cells. However, what causes these overworked nerve cells to disintegrate is unknown.
The purpose of this study is to apply specific scientific tests to answer important questions about the causes and development of the post-polio syndrome. Researchers will investigate possible genetic, immunologic, and physiologic causes of the "post-polio syndrome". The study itself will not provide therapy for patients with the condition, but may lead to the development of therapies in the future.
Read the detailed description
"Post-polio syndrome" defines the new muscle weaknesses and the variety of new difficulties with daily living that some patients experience 25-35 years after maximum recovery from acute paralytic poliomyelitis. The new weakness appears to be due to disintegration of the distal nerve terminals of the surviving motor neurons whose soma has been stressed for years to maintain large motor units via excessive distal sprouting. The factors responsible for the disintegration of axonal sprouts and manifestation of the new weakness and fatigue are unknown. Whether an immune response to the poliovirus, immunogenetic, dysimmune or aging factors play a role in the pathogenesis of this process is also unknown.
The purpose of this protocol is to apply specific neuromuscular, electrophysiological, histological, virological, and immunological tests to answer pertinent questions regarding the pathogenesis of the post-polio syndrome. Studied patients will undergo a series of clinical neuromuscular evaluations, quantitative muscle testing, electromyography including single fiber EMG, immunogenetic, viral and immunochemical studies in the serum and spinal fluid, muscle biopsy and swallowing evaluation. Although this is not a therapeutic study, the information obtained would help us understand the pathogenetic mechanisms of the new weakness and could help us design possible therapies.
- Conditions
- Poliomyelitis, Postpoliomyelitis Syndrome
- Keywords
- Poliomyelitis, Amyotrophic Lateral Sclerosis, Motor Neurons, Late Viral Infection, Motor Neuron Firing, Immune Defects, Post-polio Syndrome, Post-polio Motor Neuron Disease
- Medical subject headings
- Poliomyelitis, Postpoliomyelitis Syndrome, Amyotrophic Lateral Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJun 1982
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- 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
- Observational
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001185
- Sponsor's protocol ID
- 820083
- Other IDs
- 82-N-0083
- Status last verified
- May 2003
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Dalakas MC, Elder G, Hallett M, Ravits J, Baker M, Papadopoulos N, Albrecht P, Sever J. A long-term follow-up study of patients with post-poliomyelitis neuromuscular symptoms. N Engl J Med. 1986 Apr 10;314(15):959-63. doi: 10.1056/NEJM198604103141505.
PubMed 3007983Dalakas M. Postpolio syndrome. Curr Opin Rheumatol. 1990 Dec;2(6):901-7. doi: 10.1097/00002281-199002060-00005. No abstract available.
PubMed 2083155Sonies BC, Dalakas MC. Dysphagia in patients with the post-polio syndrome. N Engl J Med. 1991 Apr 25;324(17):1162-7. doi: 10.1056/NEJM199104253241703.
PubMed 2011159
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Polio Motor Neuron Disease: Clinical, Virological, and Immunological Studies
- ClinicalTrials.gov ID
- NCT00001185
- Acronym / sponsor ID
- 820083
- Conditions
- Poliomyelitis, Postpoliomyelitis Syndrome
- Keywords
- Poliomyelitis, Amyotrophic Lateral Sclerosis, Motor Neurons, Late Viral Infection, Motor Neuron Firing, Immune Defects, Post-polio Syndrome, Post-polio Motor Neuron Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 1982
- Study completion
- May 2003
- First posted
- 4 Nov 1999 (estimated)
- 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.
Polio or poliomyelitis is the disease caused by the poliovirus. The virus attacks cells in the spinal cord and causes symptoms of fever, sore throat, headache, vomiting, and stiffness of the neck. Patients with polio can have long-term weakness of muscles as a result of the damaged cells in the spinal cord. Occasionally, patients that recover from the disease can experience a relapse of muscle weakness. This can occur as long as 25-35 years after first having polio. The condition is called "post-polio syndrome".
Not all nerve cells in the spinal cord are damaged by the poliovirus. Some nerve cells remain healthy and take over the work of the damaged cells. Researchers believe that the "post-polio syndrome" may be caused by failure of these overworked nerve cells. However, what causes these overworked nerve cells to disintegrate is unknown.
The purpose of this study is to apply specific scientific tests to answer important questions about the causes and development of the post-polio syndrome. Researchers will investigate possible genetic, immunologic, and physiologic causes of the "post-polio syndrome". The study itself will not provide therapy for patients with the condition, but may lead to the development of therapies in the future.
Detailed description
"Post-polio syndrome" defines the new muscle weaknesses and the variety of new difficulties with daily living that some patients experience 25-35 years after maximum recovery from acute paralytic poliomyelitis. The new weakness appears to be due to disintegration of the distal nerve terminals of the surviving motor neurons whose soma has been stressed for years to maintain large motor units via excessive distal sprouting. The factors responsible for the disintegration of axonal sprouts and manifestation of the new weakness and fatigue are unknown. Whether an immune response to the poliovirus, immunogenetic, dysimmune or aging factors play a role in the pathogenesis of this process is also unknown.
The purpose of this protocol is to apply specific neuromuscular, electrophysiological, histological, virological, and immunological tests to answer pertinent questions regarding the pathogenesis of the post-polio syndrome. Studied patients will undergo a series of clinical neuromuscular evaluations, quantitative muscle testing, electromyography including single fiber EMG, immunogenetic, viral and immunochemical studies in the serum and spinal fluid, muscle biopsy and swallowing evaluation. Although this is not a therapeutic study, the information obtained would help us understand the pathogenetic mechanisms of the new weakness and could help us design possible therapies.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with prior history of a well documented acute paralytic poliomyelitis with or without development of new neuromuscular symptoms after a minimum of 15 years from the acute illness will be studied.
- Patients will be screened in the outpatient clinic and will be studied as inpatients (or, if stable, as outpatients) for three day stay.
- Severly disabled patients with unstable respiratory function or those who require intensive care nursing or respiratory assistance will be excluded from the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 3007983Dalakas MC, Elder G, Hallett M, Ravits J, Baker M, Papadopoulos N, Albrecht P, Sever J. A long-term follow-up study of patients with post-poliomyelitis neuromuscular symptoms. N Engl J Med. 1986 Apr 10;314(15):959-63. doi: 10.1056/NEJM198604103141505.
- Background: PubMed 2083155Dalakas M. Postpolio syndrome. Curr Opin Rheumatol. 1990 Dec;2(6):901-7. doi: 10.1097/00002281-199002060-00005. No abstract available.
- Background: PubMed 2011159Sonies BC, Dalakas MC. Dysphagia in patients with the post-polio syndrome. N Engl J Med. 1991 Apr 25;324(17):1162-7. doi: 10.1056/NEJM199104253241703.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poliomyelitis and Postpoliomyelitis Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 3 inclusion and 0 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 4 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001185, which also lists 3 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 4 Mar 2008.