NCT04430686

Brief Summary

Respiratory failure is the leading cause of death in motor neuron disease (MND) patients. Symptoms of respiratory dysfunction in MND patients include sleep disturbance, excessive daytime somnolence, morning headaches and cognitive changes. Almost all MND patients will develop respiratory problems during the course of their disease. In a small percentage of MND patients, respiratory failure may present as the primary symptom at onset, whereas more commonly it develops later in the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

June 10, 2020

Last Update Submit

September 21, 2021

Conditions

Motor Neuron DiseasePneumonia

Outcome Measures

Primary Outcomes (1)

  • Overall survival after initiation of assisted ventilation

    1 year

Secondary Outcomes (3)

  • Survival at one month and six months or longer

    1 month and 6 months

  • Quality of life assessed using validated health status questionnaires

    1 year

  • Time of initiation of diagnosis of MND and initiation of NIV

    1 year

Interventions

QuestionairesOTHER

Any validated functional rating scale, such as the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) or the ALSFRS-Revised (if available)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient population with ALS

You may qualify if:

  • Patients with ALS

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LiverpoolUHNHS

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Motor Neuron DiseasePneumonia

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesNeuromuscular DiseasesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

June 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

We will make the research available to any MND researchers/patients

Locations

GB(1)