Disease biomarkers in amyotrophic lateral sclerosis/motor neuron disease

ISRCTN	ISRCTN28270972
DOI	https://doi.org/10.1186/ISRCTN28270972
Secondary identifying numbers	6160

Submission date: 11/08/2010
Registration date: 11/08/2010
Last edited: 12/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ching-Hua Lu
Scientific

Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Email	chinghua.lu@gmail.com

Study information

Study design	Multicentre non-randomised interventional diagnosis trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Disease biomarkers in amyotrophic lateral sclerosis/motor neuron disease
Study acronym	ALS Biomarkers Study
Study objectives	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(s)	MREC, ref: 09/H0703/27
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	24/06/2009
Completion date	01/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 100; UK sample size: 100
Key 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
Key exclusion criteria	ALS/motor neuron disease (MND) patients unable to consent
Date of first enrolment	24/06/2009
Date of final enrolment	01/02/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Neurology

London
WC1N 3BG
United Kingdom

Sponsor information

Barts and The London NHS Trust (UK)
Hospital/treatment centre

9 Prescot Street
London
E1 8PR
England
United Kingdom

Website	http://www.bartsandthelondon.nhs.uk/
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Charity

Motor Neurone Disease Association (UK) (ref: Mal.../Apr08/RF/6039)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): MND Association, MNDA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/06/2015		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

12/09/2016: Publication reference added.