Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

Amyotrophic Lateral Sclerosis Clinical Trial

— ChALSR  

Official title:

Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328675
• Other study ID #: FDongsheng-81873784
• Status: Recruiting
• Start date: March 20, 2020
• Est. completion date: March 20, 2023

Study information

• Verified date: March 2020
• Source: Peking University Third Hospital
• Contact: Dongsheng Fan, MD, PhD
• Phone: +86-15611908107
• Email: dsfan[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A multi-center registration study of natural history and clinical characteristics of ALS in mainland China

Description:

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4752
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria

• Age: 18-70 years

Exclusion Criteria:

• Refuse to cooperate or reject the informed consent

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Survival	The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing.	through study completion, an average of 3 month
Secondary	Overall Survival	The length of time from the date of diagnosis to patient death due to any cause or the last confirmed survival.	through study completion, an average of 3 month
Secondary	Rate of disease progression	The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score from the diagnosis time to the follow-up time. ALSFRS-R values from 0 to 48 and it implies better outcome when it is higher.	through study completion, an average of 3 month
Secondary	Rate of Weight decline	The slope of decline of weight	through study completion, an average of 3 month
Secondary	Rate of BMI decline	The slope of decline of BMI	through study completion, an average of 3 month
Secondary	Rate of Forced Vital Capacity (FVC)	The slope of decline of Forced Vital Capacity (FVC) to assess the respiratory function.	through study completion, an average of 3 month