Amyotrophic Lateral Sclerosis: a New Paradigm

NCT ID: NCT03073239

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyotrophic Lateral Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ALS epidemiological characterization

epidemiological characterization

ALS patients epidemiological caracterization

Intervention Type OTHER

Epidemiological characterization in ALS patients

Genetic findings in ALS patients

genética characterization

ALS patients genetic characterization

Intervention Type GENETIC

Genetic findings in ALS patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALS patients genetic characterization

Genetic findings in ALS patients

Intervention Type GENETIC

ALS patients epidemiological caracterization

Epidemiological characterization in ALS patients

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Conde, Bebiana, M.D.

INDIV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bebiana Conde, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Tras-os-Montes e Alto Douro

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Hospitalar Tras-os-Montes e Alto Douro

Vila Real, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

sCD163 in ALS Patients
NCT02325375 COMPLETED
ALS Research Collaborative
NCT06885918 RECRUITING