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ISRCTN
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ISRCTN16782845
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ClinicalTrials.gov identifier
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Public title
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A randomised, double-blind, placebo-controlled, cross-over pilot study using nabilone for symptomatic relief in patients with Huntington's disease
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Scientific title
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Acronym
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N/A
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Serial number at source
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Sponsor 583; Eudract test 0000632-21
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Study hypothesis
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That nabilone will have a beneficial effect on movement and psychiatric symptoms in patients with Huntington's disease
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double blind placebo controlled crossover group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Huntington's disease
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Participants - inclusion criteria
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Competent patients with a clinical diagnosis of Huntington's disease over 18
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Participants - exclusion criteria
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1. Under 18
2. Known allergy to cannabinoids
3. Liver dysfunction
4. Personal or family history of psychosis
5. Heart disease or hypertension
6. Pregnant or lactating
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Anticipated start date
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01/09/2005
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Anticipated end date
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01/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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Nabilone or placebo for 5 weeks, 5 week washout period cross over to nabilone or placebo for 5 weeks
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Primary outcome measure(s)
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Motor symptoms rated using the motor scale from the UHDRS
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Secondary outcome measure(s)
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Psychiatric symptoms rated using the behavioural assessment of the UHDRS and the NPI
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Sources of funding
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Cambridge Laboratories (UK) - hold the European marketing rights for nabilone
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Trial website
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Publications
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Contact name
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Dr
Hugh
Rickards
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Address
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Queen Elizabeth Psychiatric Hospital
Vincent Drive
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2QZ
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Country
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United Kingdom
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Tel
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+44 (0)121 678 2019
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Fax
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+44 (0)121 678 2079
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Email
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hugh.rickards@bsmht.nhs.uk
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Sponsor
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Birmingham and Solihull Mental Health Trust (UK)
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Address
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Uffculme Centre
Queensbridge Road
Moseley
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City/town
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Birmingham
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Zip/Postcode
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B13 8QY
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Country
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United Kingdom
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Tel
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+44 (0)121 678 2731
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Fax
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+44 (0)121 678 2730
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Email
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theresa.morton@bsmht.nhs.uk
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Date applied
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07/09/2005
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Last edited
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07/10/2009
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Date ISRCTN assigned
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13/09/2005
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