Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/10/2009
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 Paul M Matthews

ORCID ID

Contact details

John Radcliffe Hospital
FMRIB Centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222493
paul@fmrib.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176079579

Study information

Scientific title

Acronym

Study hypothesis

1. To examine the relationship between magnetic resonance imaging (MRI) indices and the severity of cognitive symptoms (e.g. poor memory and concentration)
2. To evaluate whether Rivastigmine Tartrate has a beneficial effect on the cognitive performance of patients with MS

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Multiple sclerosis (MS)

Intervention

Randomised placebo controlled, single dose, crossover trial with MRI and behavioural endpoints.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Behavioural data during performance of the functional imaging task and in the formal cognitive assessment
2. Absolute measures of signal intensity change in regions of interest in the functional scan
3. Lesion load on T1 and T2 weighted MRI scans
4. The percentage of the white matter in the patient that has T1 values greater than normal

Secondary outcome measures

1. Behavioural effect on other tasks within the neuropsychological battery
2. Possible side effects

Overall trial start date

01/11/2000

Overall trial end date

01/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

12 Healthy people. 24 Patients.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2000

Recruitment end date

01/11/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12958082

Publication citations

  1. Results

    Parry AM, Scott RB, Palace J, Smith S, Matthews PM, Potentially adaptive functional changes in cognitive processing for patients with multiple sclerosis and their acute modulation by rivastigmine., Brain, 2003, 126, Pt 12, 2750-2760, doi: 10.1093/brain/awg284.

Additional files

Editorial Notes