Amyotrophic Lateral Sclerosis: a New Paradigm

Amyotrophic Lateral Sclerosis Clinical Trial

— ALSParadigm  

Official title:

Amyotrophic Lateral Sclerosis: a New Paradigm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073239
• Other study ID #: 2
• Status: Completed
• Start date: December 2016
• Est. completion date: June 2018

Study information

• Verified date: March 2017
• Source: Conde, Bebiana, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Other:
• ALS patients epidemiological caracterization
Epidemiological characterization in ALS patients

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Tras-os-Montes e Alto Douro	Vila Real

Sponsors (1)

Lead Sponsor	Collaborator
Conde, Bebiana, M.D.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finding environmental risk factor	Apply epidemiogycal form to All ALS patients sentido to respiratory evaluation in 2 years.	2 years
Secondary	Regional prevalence	Identify All cases ALS in regional area ( in north of Portugal)	1 year
Secondary	Finding a genetic marker	Scan all ALS patients to eventually finding new ALS genes	2 years