NCT04953624

Brief Summary

Chinese cnaq scale was used to evaluate the appetite changes of Chinese ALS patients; Objective to investigate the related factors of appetite changes in ALS patients; Objective to investigate the effect of anorexia on the progression and survival of ALS patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

June 27, 2021

Last Update Submit

July 7, 2021

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (9)

  • ALSFRS-R score

    3 months

  • ALSFRS-R score

    6 months

  • ALSFRS-R score

    12 months

  • Food intake

    Inability to eat

    3 months

  • Food intake

    Inability to eat

    6 months

  • Food intake

    Inability to eat

    12 months

  • invasive ventilator or death

    end point events

    3 months

  • invasive ventilator or death

    end point events

    6 months

  • invasive ventilator or death

    end point events

    12 months

Study Arms (2)

CNAQ≤28

ALS patients with CNAQ ≤ 28

Diagnostic Test: Appetite rating scale CNAQ

CNAQ>28

ALS patients with CNAQ \> 28

Diagnostic Test: Appetite rating scale CNAQ

Interventions

Appetite rating scale CNAQDIAGNOSTIC_TEST

Chinese version of Appetite rating scale CNAQ

CNAQ>28CNAQ≤28

Eligibility Criteria

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

ALS patients

You may qualify if:

  • ALS patients diagnosed as probable, or definite according to the revised El Escorial criteria

You may not qualify if:

  • there are other chronic consumption diseases such as severe digestive system diseases, thyroid diseases, diabetes and so on.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100098, China

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

Study Officials

  • Dongsheng Fan

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Fan

CONTACT

+86 13701023871dsfan@sina.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 8, 2021

Study Start

August 1, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Locations

CN(1)