NCT07175935

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
57mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Mar 2025Dec 2030

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

5.8 years

First QC Date

August 27, 2025

Last Update Submit

September 14, 2025

Conditions

Keywords

Amyotrophic Lateral SclerosisEpidemiologicalNatural History

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 years

Secondary Outcomes (7)

  • ALS Functional Decline

    10 years

  • Disease Staging Progression

    10 years

  • Respiratory Outcomes

    10 years

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

    10 years

  • Cognitive and Behavioral Profile

    10 years

  • +2 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALS patients attending university hospitals, tertiary neuromuscular clinics, and referral hospitals in Thailand.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial hospital, The Thai Red Cross Society

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Jakkrit Amornvit, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priciple Investigator

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 16, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
IPD will be available beginning 6-12 months after publication of the primary results and for up to 5 years thereafter.
Access Criteria
Requests for access should be directed to the Principal Investigator via institutional contact email. Applicants will be required to submit a research proposal outlining objectives, methods, and intended use of the data. Approval will be contingent on adherence to ethical and scientific standards, and execution of a data sharing agreement.

Locations