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NCT Number: NCT07175935

Amyotrophic Lateral Sclerosis Registry 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.

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Key information

Conditions

ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ALS according to El Escorial or Gold Coast criteria
  • Age ≥ 18 years
  • Ability and willingness to provide informed consent

Exclusion criteria

  • Patients unwilling to provide informed consent
  • Patients with alternative diagnoses mimicking ALS

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. ALS Functional Decline

    Time frame: 10 years

    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.

  2. Disease Staging Progression

    Time frame: 10 years

    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.

  3. Respiratory Outcomes

    Time frame: 10 years

    Measure: Forced vital capacity (FVC % predicted).

    Time Frame: Every 6-12 months.

    Outcome: Decline in FVC

  4. Changes in health-related quality of life over time.

    Time frame: 10 years

    Measure: EQ-5D-5L.

    Time Frame: Annually.

    Outcome: Changes in health-related quality of life over time.

  5. Cognitive and Behavioral Profile

    Time frame: 10 years

    Measure: Edinburgh Cognitive and Behavioral ALS Screen (ECAS)

    Time Frame: Annually.

    Outcome: Frequency and pattern of cognitive/behavioral impairment in ALS patients.

  6. Genetic and Environmental Risk Associations

    Time frame: 10 years

    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.

  7. Healthcare Utilization and Treatment Patterns

    Time frame: 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakkrit Amornvit, MD

CONTACT

[email protected]

+66622169338

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

A Prospective, Multicenter Registry Study of Amyotrophic Lateral Sclerosis in Thailand

Acronym: Thai ALS Regis

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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