Condition category
Nervous System Diseases
Date applied
11/08/2010
Date assigned
11/08/2010
Last edited
12/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ching-Hua Lu

ORCID ID

Contact details

Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
-
chinghua.lu@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6160

Study information

Scientific title

Disease biomarkers in amyotrophic lateral sclerosis/motor neuron disease

Acronym

ALS Biomarkers Study

Study hypothesis

This study will evaluate the expression of neurofilaments and of other relevant molecules in blood samples taken from individuals with amyotrophic lateral sclerosis at different time points during the development of the disease. Our aim is to validate easily accessible disease biomarkers functioning as reliable predictors of disease severity and capable of providing information about the stratification of the disease phenotypes. Control groups will include healthy individuals and patients with a compressive radiculopathy. Recruitment will take place in four motor neuron disease clinics serving a population of approximately 7,000,000 in North-East London, Herefordshire and Essex. A similar study is currently ongoing in animal models of the disease.

Ethics approval

MREC, ref: 09/H0703/27

Study design

Multicentre non-randomised interventional diagnosis trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Motor neurone disease; Disease: Motor neurone disease

Intervention

1. Blood tests
2. Venepuncture
Study entry: registration only

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The rate of neurological decline as measured by the ALS Functional Rating Scale Revised (ALSFR)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/06/2009

Overall trial end date

01/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial Criteria
2. Greater than 16 years of age, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 100; UK sample size: 100

Participant exclusion criteria

ALS/motor neuron disease (MND) patients unable to consent

Recruitment start date

24/06/2009

Recruitment end date

01/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Neurology
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

Barts and The London NHS Trust (UK)

Sponsor details

9 Prescot Street
London
E1 8PR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.bartsandthelondon.nhs.uk/

Funders

Funder type

Charity

Funder name

Motor Neurone Disease Association (UK) (ref: Mal.../Apr08/RF/6039)

Alternative name(s)

MNDA

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25934855

Publication citations

Additional files

Editorial Notes

12/09/2016: Publication reference added.