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Trial record 1 of 477 for:    Amyotrophic Lateral Sclerosis (ALS)
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Amyotrophic Lateral Sclerosis: a New Paradigm (ALSParadigm)

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ClinicalTrials.gov Identifier: NCT03073239
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Conde, Bebiana, M.D.

Brief Summary:

Amyotrophic Lateral Sclerosis (ALS) is a degenerative neuromuscular disease, progressing inexorably to respiratory failure, the by involvement of respiratory muscles, the commitment with most impact on the prognosis of ALS.

According to current knowledge, the clinical presentation of the disease is characterized by spinal or bulbar involvement, the latter being associated with a worse prognosis.

There are multiple factors described in the aetiology of ALS, as the successive damage the motor neuron, which can happen in high-impact athletes, or exposure to heavy metals. Genetic mutations are also described, being associated to a higher prevalence of ALS.

Data from retrospective studies with ALS populations reveal a prevalence of 4-8 cases per 100,000 persons. Research carried out in Trás-os-Montes e Alto Douro region (Northeast of Portugal) shows a high prevalence of ALS, with near 10 cases per 100,000 persons, with a recent increase in the bulbar involvement. The reasons for the high prevalence of ALS in this region are unknown.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Genetic: ALS patients genetic characterization Other: ALS patients epidemiological caracterization

Detailed Description:
The objective of this research is to pursue potentially involved genetic mutations in this disease (new or previously described), in addition to carry out a epidemiological questionnaire including data on personal history, environmental and occupational exposure that might be underlying this high prevalence.

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Amyotrophic Lateral Sclerosis: a New Paradigm
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : June 2018


Group/Cohort Intervention/treatment
ALS epidemiological characterization
epidemiological characterization
Other: ALS patients epidemiological caracterization
Epidemiological characterization in ALS patients

Genetic findings in ALS patients
genética characterization
Genetic: ALS patients genetic characterization
Genetic findings in ALS patients




Primary Outcome Measures :
  1. Finding environmental risk factor [ Time Frame: 2 years ]
    Apply epidemiogycal form to All ALS patients sentido to respiratory evaluation in 2 years.


Secondary Outcome Measures :
  1. Regional prevalence [ Time Frame: 1 year ]
    Identify All cases ALS in regional area ( in north of Portugal)

  2. Finding a genetic marker [ Time Frame: 2 years ]
    Scan all ALS patients to eventually finding new ALS genes


Biospecimen Retention:   Samples With DNA
blood to test als mutations


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Amyotrophic Lateral Sclerosis sent to a medical consultation
Criteria

Inclusion Criteria:

  • All patients with Amyotrophic Lateral Sclerosis sent to a medical consultation

Exclusion Criteria:

  • Amyotrophic Lateral Sclerosis not confirmed
  • Ages less than 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073239


Locations
Portugal
Centro Hospitalar Tras-os-Montes e Alto Douro
Vila Real, Portugal, 5000
Sponsors and Collaborators
Conde, Bebiana, M.D.
Investigators
Principal Investigator: Bebiana Conde, MD Centro Hospitalar Tras-os-Montes e Alto Douro

Responsible Party: Conde, Bebiana, M.D.
ClinicalTrials.gov Identifier: NCT03073239     History of Changes
Other Study ID Numbers: 2
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research results will be shared with the scientific community through the publication of 2 to 3 papers in medical journals, as well as through the participation in national and international conferences. Whenever requested by the participants, the individual data resulting from clinical examinations will be provided.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Conde, Bebiana, M.D.:
Amyotrophic Lateral Sclerosis
Bulbar disfunction
Rik factors ALS

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases