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Cannabinoids in Progressive Inflammatory brain Disease (CUPID)
ISRCTN ISRCTN62942668
DOI 10.1186/ISRCTN62942668
ClinicalTrials.gov identifier
EudraCT number
Public title Cannabinoids in Progressive Inflammatory brain Disease (CUPID)
Scientific title
Acronym CUPID
Serial number at source G0500290
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval South West Devon Research Ethics Committee (now Cornwall and Plymouth Research Ethics Committee) approved on the 28th of February 2006 (ref: 06/Q2103/1)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Multiple sclerosis
Participants - inclusion criteria 1. Primary/secondary progressive multiple sclerosis
2. Worsening disability
3. Age 18-65
4. EDSS score 4 to 6.5
Participants - exclusion criteria 1. Immunodulation or immunosuppressive therapy
2. Steroids or cannabinoids recently
3. Psychotic illness
4. Cognitive impairment
5. Pregnancy
Anticipated start date 01/07/2005
Anticipated end date 30/06/2011
Status of trial Completed
Patient information material
Target number of participants 500
Interventions 2:1 ratio, Tetrahydrocannabinol: Placebo
Primary outcome measure(s) 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.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Medical Research Council (MRC) (UK) - G0500290
Trial website http://www.pms.ac.uk/cnrg/cupid
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23856559
Contact name Prof  John  Zajicek
  Address Peninsula Medical School
University of Exeter
Room N16
ITTC Building
Tamar Science Park
  City/town Plymouth
  Zip/Postcode PL6 8BX
  Country United Kingdom
  Tel +44 (0)1752 315271
  Email John.zajicek@pcmd.ac.uk
Sponsor Plymouth Hospitals NHS Trust (UK)
  Address Rm N17
ITTC Building
Tamar Science Park
  City/town Plymouth
  Zip/Postcode PL6 8BX
  Country United Kingdom
  Tel +44 (0)1752 315 114
  Email Lisa.Vickers@phnt.swest.nhs.uk
Date applied 03/05/2005
Last edited 17/07/2013
Date ISRCTN assigned 21/06/2005
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