Amyotrophic Lateral SclerosisALSParadigmNCT03073239
Amyotrophic Lateral Sclerosis: a New Paradigm
An observational study of Amyotrophic Lateral Sclerosis, run by Conde, Bebiana, M.D. at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- ALS patients genetic characterization and ALS patients epidemiological caracterization
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- Dec 2016to Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Amyotrophic Lateral Sclerosis sent to a medical consultation
Who may be able to join
- All patients with Amyotrophic Lateral Sclerosis sent to a medical consultation
Who cannot join
- Amyotrophic Lateral Sclerosis not confirmed
- Ages less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- ALS patients genetic characterization, ALS patients epidemiological caracterization
- Keywords
- Amyotrophic Lateral Sclerosis, Bulbar disfunction, Rik factors ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS patients genetic characterizationGenetic
Genetic findings in ALS patients
ALS patients epidemiological caracterizationOther
Epidemiological characterization in ALS patients
| Study group | Role | What they receive |
|---|---|---|
| ALS epidemiological characterization | epidemiological characterization Receives: Other: ALS patients epidemiological caracterization | |
| Genetic findings in ALS patients | genética characterization Receives: Genetic: ALS patients genetic characterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finding environmental risk factor
Apply epidemiogycal form to All ALS patients sentido to respiratory evaluation in 2 years.
Measured: 2 years
Secondary outcomes (2)
Regional prevalence
Identify All cases ALS in regional area ( in north of Portugal)
Measured: 1 year
Finding a genetic marker
Scan all ALS patients to eventually finding new ALS genes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startDec 2016
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conde, Bebiana, M.D.
- Responsible party
- Sponsor
- Investigators
- Bebiana Conde, MD, Principal investigator, Centro Hospitalar Tras-os-Montes e Alto Douro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073239
- Sponsor's protocol ID
- 2
- Acronym
- ALSParadigm
- Status last verified
- Mar 2017
- First submitted
- 26 Mar 2016
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyotrophic Lateral Sclerosis: a New Paradigm
- ClinicalTrials.gov ID
- NCT03073239
- Acronym / sponsor ID
- ALSParadigm / 2
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Bulbar disfunction, Rik factors ALS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Conde, Bebiana, M.D.
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 8 Mar 2017 (actual)
- 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS epidemiological characterization | – | Other: ALS patients epidemiological caracterizationepidemiological characterization |
| Genetic findings in ALS patients | – | Genetic: ALS patients genetic characterizationgenética characterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Amyotrophic Lateral Sclerosis sent to a medical consultation
Key inclusion criteria (1 listed)
- All patients with Amyotrophic Lateral Sclerosis sent to a medical consultation
Key exclusion criteria (2 listed)
- Amyotrophic Lateral Sclerosis not confirmed
- Ages less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALS patients genetic characterizationGenetic findings in ALS patients | Genetic | Genetic findings in ALS patients |
| ALS patients epidemiological caracterizationEpidemiological characterization in ALS patients | Other | ALS epidemiological characterization |
Primary outcome
Finding environmental risk factor
Time frame: 2 years
Apply epidemiogycal form to All ALS patients sentido to respiratory evaluation in 2 years.
2 secondary outcomes
Regional prevalence
Time frame: 1 year
Finding a genetic marker
Time frame: 2 years
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 23 Jul 2018.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Amyotrophic Lateral Sclerosis
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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.
Bebiana Conde, MD principal investigator
Centro Hospitalar Tras-os-Montes e Alto Douro
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 Amyotrophic Lateral Sclerosis, run by Conde, Bebiana, M.D. at 1 site in Portugal.
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 1 inclusion and 2 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 23 Jul 2018. 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 Portugal. 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.
What does the primary outcome measure?
Finding environmental risk factor (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2018.