Condition category
Not Applicable
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/12/2010
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

Prof Paul Grasby

ORCID ID

Contact details

c/o Lindsay Green
Assistant Direct
MRC Cyclotron Unit PET Neuroscience
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 3162
paul.grasby@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016131985

Study information

Scientific title

Acronym

Study hypothesis

1. To measure binding of [11C]FLB 457 after the administration of methylphenidate and placebo in normal volunteers.
2. To determine if [11C]FLB 457 is displaceable in extra-striatal regions of the brain.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Not Applicable: Metabolism

Intervention

Double-blind, placebo controlled, randomised study to measure binding of [11C]FLB 457 after the administration of methylphenidate and placebo in normal volunteers.

Intervention type

Drug

Phase

Not Specified

Drug names

methylphenidate

Primary outcome measures

To measure accurately extra-striatal dopamine D2 receptor density in man. If [11C]FLB 457 is displaceable from extrastriatal D2 receptors, it will have great potential value for the measurement of extrastriatal dopamine levels.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/09/2001

Overall trial end date

03/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Volunteers: 16. Males 25-65 yrs, females 45-65 yrs.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

16

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

02/09/2001

Recruitment end date

03/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Lindsay Green, Assistant Direct
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Hammersmith Hospital NHS Trust

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/16685253

Publication citations

  1. Results

    Montgomery AJ, Asselin MC, Farde L, Grasby PM, Measurement of methylphenidate-induced change in extrastriatal dopamine concentration using [11C]FLB 457 PET., J. Cereb. Blood Flow Metab., 2007, 27, 2, 369-377, doi: 10.1038/sj.jcbfm.9600339.

Additional files

Editorial Notes