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Recruiting NCT07175935

Amyotrophic Lateral Sclerosis Registry in Thailand

Observational ALS (Amyotrophic Lateral Sclerosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ALS (Amyotrophic Lateral Sclerosis). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Survival [Time frame: 10 years]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Thailand · 1 center
  • King Chulalongkorn Memorial hospital, The Thai Red Cross Society — Pathum Wan

Identifiers

NCT: NCT07175935 · COA No. 0262/2025 · NST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗