ALS (Amyotrophic Lateral Sclerosis)Thai ALS RegisNCT07175935
Amyotrophic Lateral Sclerosis Registry in Thailand
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This is a prospective, observational, multicenter registry designed to collect comprehensive clinical, genetic, and outcome data from patients diagnosed with amyotrophic lateral sclerosis (ALS) across Thailand. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2025to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ALS patients attending university hospitals, tertiary neuromuscular clinics, and referral hospitals in Thailand.
Who may be able to join
- Diagnosis of ALS according to El Escorial or Gold Coast criteria
- Age ≥ 18 years
- Ability and willingness to provide informed consent
Who cannot join
- Patients unwilling to provide informed consent
- Patients with alternative diagnoses mimicking ALS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial hospital, The Thai Red Cross Society
Pathum Wan, Bangkok, 10330
Jakkrit Amornvit, MD, +66622169338, jakkrit.a@chula.ac.th
Phuettha Sangrut, MSc, 022564000 ext. 80722, phuettha.s@chulahospital.org
About this study
Official title: A Prospective, Multicenter Registry Study of Amyotrophic Lateral Sclerosis in Thailand
This is a prospective, observational, multicenter registry designed to collect comprehensive clinical, genetic, and outcome data from patients diagnosed with amyotrophic lateral sclerosis (ALS) across Thailand. The registry will establish a national dataset to describe epidemiology, clinical presentation, progression, and treatment outcomes, and will serve as a platform for future clinical and translational research.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder that affects upper and lower motor neurons, leading to progressive muscle weakness, disability, and respiratory failure. Despite increasing research worldwide, Thailand lacks large-scale systematic data on ALS epidemiology, clinical characteristics, genetic profiles, and outcomes.
This registry will prospectively enroll ALS patients from major academic hospitals and specialized neuromuscular centers nationwide. Patients will be followed longitudinally using standardized assessments, including ALSFRS-R, staging systems (King, MiTos, 9-point), motor and respiratory function, quality-of-life measures, and cognitive/behavioral evaluations.
Data will be collected through a REDCap electronic database, ensuring confidentiality and compliance with Thai PDPA and international data protection standards. No experimental interventions will be performed; patients will receive standard of care treatments as determined by their treating physicians.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- Amyotrophic Lateral Sclerosis, Epidemiological, Natural History
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Time Frame: From enrollment until death from any cause (assessed continuously, with updates at each follow-up).
Outcome: Overall survival in ALS patients across Thailand, with survival curves stratified by demographic, clinical, and genetic factors.
Measured: 10 years
Secondary outcomes (7)
ALS Functional Decline
Measure: Change in ALS Functional Rating Scale-Revised (ALSFRS-R) score.
Time Frame: Every 6-12 months.
Outcome: Rate of functional decline, expressed as points lost per month/year.
Measured: 10 years
Disease Staging Progression
Measure: King's and MiToS staging systems, 9-point staging.
Time Frame: Every 6-12 months.
Outcome: Proportion of patients progressing to higher stages; median time to stage transitions.
Measured: 10 years
Respiratory Outcomes
Measure: Forced vital capacity (FVC % predicted).
Time Frame: Every 6-12 months.
Outcome: Decline in FVC
Measured: 10 years
Changes in health-related quality of life over time.
Measure: EQ-5D-5L.
Time Frame: Annually.
Outcome: Changes in health-related quality of life over time.
Measured: 10 years
Cognitive and Behavioral Profile
Measure: Edinburgh Cognitive and Behavioral ALS Screen (ECAS)
Time Frame: Annually.
Outcome: Frequency and pattern of cognitive/behavioral impairment in ALS patients.
Measured: 10 years
Genetic and Environmental Risk Associations
Measure: Frequency of ALS-associated genetic variants (e.g., SOD1, C9orf72, TARDBP, FUS) and correlation with clinical phenotype and progression.
Time Frame: As available.
Outcome: Genotype-phenotype correlation; association with disease onset, progression, and survival.
Measured: 10 years
Healthcare Utilization and Treatment Patterns
Measure: Use of riluzole, edaravone, non-invasive ventilation, gastrostomy, and multidisciplinary ALS clinic care.
Time Frame: Throughout follow-up.
Outcome: Patterns of treatment access and their association with survival and quality of life.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakkrit Amornvit, MD., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175935
- Sponsor's protocol ID
- COA No. 0262/2025
- Other IDs
- NST
- Acronym
- Thai ALS Regis
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results of this study (including clinical, demographic, and outcome measures) will be made available to qualified researchers upon reasonable request, following publication of the primary results. Access will be provided to investigators whose proposed use of the data has been approved by an independent review committee to ensure scientific merit and compliance with ethical standards. Data will be shared through secure data transfer under a data sharing agreement that protects participant confidentiality. Supporting documents, including the study protocol, statistical analysis plan, and informed consent form, will also be made available where applicable.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Registry Study of Amyotrophic Lateral Sclerosis in Thailand
- ClinicalTrials.gov ID
- NCT07175935
- Acronym / sponsor ID
- Thai ALS Regis / COA No. 0262/2025
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- Amyotrophic Lateral Sclerosis, Epidemiological, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Sep 2025 (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.
This is a prospective, observational, multicenter registry designed to collect comprehensive clinical, genetic, and outcome data from patients diagnosed with amyotrophic lateral sclerosis (ALS) across Thailand. The registry will establish a national dataset to describe epidemiology, clinical presentation, progression, and treatment outcomes, and will serve as a platform for future clinical and translational research.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder that affects upper and lower motor neurons, leading to progressive muscle weakness, disability, and respiratory failure. Despite increasing research worldwide, Thailand lacks large-scale systematic data on ALS epidemiology, clinical characteristics, genetic profiles, and outcomes.
This registry will prospectively enroll ALS patients from major academic hospitals and specialized neuromuscular centers nationwide. Patients will be followed longitudinally using standardized assessments, including ALSFRS-R, staging systems (King, MiTos, 9-point), motor and respiratory function, quality-of-life measures, and cognitive/behavioral evaluations.
Data will be collected through a REDCap electronic database, ensuring confidentiality and compliance with Thai PDPA and international data protection standards. No experimental interventions will be performed; patients will receive standard of care treatments as determined by their treating physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ALS patients attending university hospitals, tertiary neuromuscular clinics, and referral hospitals in Thailand.
Key inclusion criteria (3 listed)
- Diagnosis of ALS according to El Escorial or Gold Coast criteria
- Age ≥ 18 years
- Ability and willingness to provide informed consent
Key exclusion criteria (2 listed)
- Patients unwilling to provide informed consent
- Patients with alternative diagnoses mimicking ALS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 10 years
Time Frame: From enrollment until death from any cause (assessed continuously, with updates at each follow-up). Outcome: Overall survival in ALS patients across Thailand, with survival curves stratified by demographic, clinical, and genetic factors.
7 secondary outcomes
ALS Functional Decline
Time frame: 10 years
Disease Staging Progression
Time frame: 10 years
Respiratory Outcomes
Time frame: 10 years
Changes in health-related quality of life over time.
Time frame: 10 years
Cognitive and Behavioral Profile
Time frame: 10 years
Genetic and Environmental Risk Associations
Time frame: 10 years
Healthcare Utilization and Treatment Patterns
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results of this study (including clinical, demographic, and outcome measures) will be made available to qualified researchers upon reasonable request, following publication of the primary results. Access will be provided to investigators whose proposed use of the data has been approved by an independent review committee to ensure scientific merit and compliance with ethical standards. Data will be shared through secure data transfer under a data sharing agreement that protects participant confidentiality. Supporting documents, including the study protocol, statistical analysis plan, and informed consent form, will also be made available where applicable.
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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.
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 ALS (Amyotrophic Lateral Sclerosis), run by Chulalongkorn University at 1 site in Thailand.
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 3 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakkrit Amornvit, MD (+66622169338, jakkrit.a@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 10 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 16 Sep 2025.