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ISRCTN
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ISRCTN62942668
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ClinicalTrials.gov identifier
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Public title
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Cannabinoids in Progressive Inflammatory brain Disease (CUPID)
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Scientific title
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Acronym
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CUPID
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Serial number at source
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G0500290
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Study hypothesis
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To test whether cannabinoids have any value in slowly progressive multiple sclerosis (MS) (i.e. have a neuroprotective action). Change in Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Impact Scale (MSIS-29) scores
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Lay summary
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Ethics approval
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South West Devon Research Ethics Committee (now Cornwall and Plymouth Research Ethics Committee) approved on the 28th of February 2006 (ref: 06/Q2103/1)
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Study design
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Randomised controlled 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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Multiple sclerosis
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Participants - inclusion criteria
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1. Primary/secondary progressive multiple sclerosis
2. Worsening disability
3. Age 18-65
4. EDSS score 4 to 6.5
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Participants - exclusion criteria
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1. Immunodulation or immunosuppressive therapy
2. Steroids or cannabinoids recently
3. Psychotic illness
4. Cognitive impairment
5. Pregnancy
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Anticipated start date
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01/07/2005
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Anticipated end date
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30/06/2011
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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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500
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Interventions
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2:1 ratio, Tetrahydrocannabinol: Placebo
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Primary outcome measure(s)
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Added 17/07/09:
1. Physician-based EDSS: time to EDSS progression of at least one point from a baseline EDSS of 4.0, 4.5 or 5.0 or at least 0.5 points from a baseline EDSS ≥5.5. Once identified, deterioration must be confirmed at the next scheduled six monthly visit.
2. Patient-based MSIS-29 physical impact scale version 2: overall mean change from baseline to end of study.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK) - G0500290
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Trial website
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http://www.pms.ac.uk/cnrg/cupid
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Publications
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Contact name
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Prof
John
Zajicek
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Address
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Peninsula Medical School
University of Exeter
Room N16
ITTC Building
Tamar Science Park
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City/town
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Plymouth
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Zip/Postcode
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PL6 8BX
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Country
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United Kingdom
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Tel
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+44 (0)1752 315271
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Email
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John.zajicek@pcmd.ac.uk
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Sponsor
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Plymouth Hospitals NHS Trust (UK)
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Address
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Rm N17
ITTC Building
Tamar Science Park
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City/town
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Plymouth
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Zip/Postcode
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PL6 8BX
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Country
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United Kingdom
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Tel
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+44 (0)1752 315 114
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Email
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Lisa.Vickers@phnt.swest.nhs.uk
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Date applied
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03/05/2005
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Last edited
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17/11/2010
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Date ISRCTN assigned
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21/06/2005
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