Plain English Summary
Background and study aims
Multiple sclerosis is the commonest cause of neurological disability in young adults, affecting around 100,000 people in the UK. Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively causing a range of disabilities, including mobility problems, problems with thinking, learning and planning (cognitive function), vision, and speech and swallowing. Around 15% of people diagnosed with MS have the primary-progressive type (PPMS). This involves the progressive worsening of disability from the onset of symptoms, without any periods of recovery. Secondary-progressive MS (SPMS), also known as late stage MS, involves the progressive worsening of disability after a relapsing-remitting phase (characterised by periods where the symptoms are very mild or disappear completely). Currently, there are limited treatment options for the progressive types of MS. It has been reported that the active ingredient of cannabis (tetrahydrocannabinol, THC) could be helpful in treating MS symptoms. The aim of this study is to find out whether THC can help to slow or stop the progression of disability in patients with progressive MS.
Who can participate?
Adults with primary or secondary progressive MS.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive THC to take by mouth every day for six months. The dosage is calculated based on body weight, but can be a maximum of 28mg/kg. Those in the second group receive a placebo (dummy pill) to take every day for six months. Participants in both groups are followed up every six months for up to 36 or 42 months. At the follow up visits, the progression (worsening) of the disease is measured using physical evaluations and a walking test, to find out if it has had an effect on disability.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Peninsula Medical School (UK)
When is the study starting and how long is it expected to run for?
July 2005 to June 2011
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Prof John Zajicek
John.zajicek@pcmd.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof John Zajicek
ORCID ID
Contact details
Peninsula Medical School
University of Exeter
Room N16
ITTC Building
Tamar Science Park
Plymouth
PL6 8BX
United Kingdom
+44 (0)1752 315271
John.zajicek@pcmd.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0500290
Study information
Scientific title
The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial
Acronym
CUPID
Study hypothesis
To test whether cannabinoids show any neuroprotective action in progressive multiple sclerosis (MS).
Ethics approval
South West Devon Research Ethics Committee (now Cornwall and Plymouth Research Ethics Committee), 28/02/2006, ref: 06/Q2103/1
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Multiple sclerosis
Intervention
Participants are randomly allocated to one of two groups in a 2:1 ratio (intervention:control)
Intervention group: Participants take a maximum of 28mg/day oral tetrahydrocannabinol (THC) for six months.
Control group: Participants take a placebo daily for six months.
Intervention type
Drug
Phase
Not Specified
Drug names
Tetrahydrocannabinol
Primary outcome measure
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. Change in Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29v2) 20-point physical subscale (MSIS-29phys) score
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2005
Overall trial end date
30/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary/secondary progressive multiple sclerosis
2. Worsening disability
3. Age 18-65
4. EDSS score 4 to 6.5
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Immunodulation or immunosuppressive therapy
2. Steroids or cannabinoids recently
3. Psychotic illness
4. Cognitive impairment
5. Pregnancy
Recruitment start date
01/07/2005
Recruitment end date
30/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Peninsula Medical School
Plymouth
PL6 8BX
United Kingdom
Sponsor information
Organisation
Plymouth Hospitals NHS Trust (UK)
Sponsor details
Rm N17
ITTC Building
Tamar Science Park
Plymouth
PL6 8BX
United Kingdom
+44 (0)1752 315 114
Lisa.Vickers@phnt.swest.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) - G0500290
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23856559
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25676540
Publication citations
-
Results
Zajicek J, Ball S, Wright D, Vickery J, Nunn A, Miller D, Gomez Cano M, McManus D, Mallik S, Hobart J, , Effect of dronabinol on progression in progressive multiple sclerosis (CUPID): a randomised, placebo-controlled trial., Lancet Neurol, 2013, 12, 9, 857-865, doi: 10.1016/S1474-4422(13)70159-5.
-
Results
Ball S, Vickery J, Hobart J, Wright D, Green C, Shearer J, Nunn A, Gomez Cano M, MacManus D, Miller D, Mallik S, Zajicek J, The Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial: a randomised double-blind placebo-controlled parallel-group multicentre trial and economic evaluation of cannabinoids to slow progression in multiple sclerosis, Health Technol Assess, 2015, 19, 12, 1-188, doi: 10.3310/hta19120.