NCT00001185

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1982

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1982

Completed
17.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

PoliomyelitisAmyotrophic Lateral SclerosisMotor NeuronsLate Viral InfectionMotor Neuron FiringImmune DefectsPost-polio SyndromePost-polio Motor Neuron Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 3007983BACKGROUND
  • Dalakas M. Postpolio syndrome. Curr Opin Rheumatol. 1990 Dec;2(6):901-7. doi: 10.1097/00002281-199002060-00005. No abstract available.

    PMID: 2083155BACKGROUND
  • Sonies 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.

    PMID: 2011159BACKGROUND

MeSH Terms

Conditions

PoliomyelitisPostpoliomyelitis SyndromeAmyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeurodegenerative DiseasesMotor Neuron DiseaseTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

June 1, 1982

Study Completion

May 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-05

Locations