Positron emission tomography (PET) measurement of the displaceability of [11C]FLB 457 from extra-striatal dopamine D2 receptors in man
| ISRCTN | ISRCTN23418225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23418225 |
| Secondary identifying numbers | N0016131985 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paul Grasby
Scientific
Scientific
c/o Lindsay Green, Assistant Direct
MRC Cyclotron Unit PET Neuroscience
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0)20 8383 3162 |
|---|---|
| paul.grasby@imperial.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | methylphenidate |
| Primary outcome measure | 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 study start date | 02/09/2001 |
| Completion date | 03/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 16 |
| Key inclusion criteria | Volunteers: 16. Males 25-65 yrs, females 45-65 yrs. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 02/09/2001 |
| Date of final enrolment | 03/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
c/o Lindsay Green, Assistant Direct
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Hammersmith Hospital NHS Trust
No information available
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 | 01/02/2007 | Yes | No |
