Cannabinoids in progressive inflammatory brain disease (CUPID)

ISRCTN ISRCTN62942668
DOI https://doi.org/10.1186/ISRCTN62942668
Secondary identifying numbers G0500290
Submission date
03/05/2005
Registration date
21/06/2005
Last edited
13/04/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Prof John Zajicek
Scientific

Peninsula Medical School
University of Exeter
Room N16
ITTC Building
Tamar Science Park
Plymouth
PL6 8BX
United Kingdom

Phone +44 (0)1752 315271
Email John.zajicek@pcmd.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe Cannabinoid Use in Progressive Inflammatory brain Disease (CUPID) trial
Study acronymCUPID
Study objectivesTo test whether cannabinoids show any neuroprotective action in progressive multiple sclerosis (MS).
Ethics approval(s)South West Devon Research Ethics Committee (now Cornwall and Plymouth Research Ethics Committee), 28/02/2006, ref: 06/Q2103/1
Health condition(s) or problem(s) studiedMultiple sclerosis
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Tetrahydrocannabinol
Primary outcome measureAdded 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 measuresNot provided at time of registration
Overall study start date01/07/2005
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants500
Key inclusion criteria1. Primary/secondary progressive multiple sclerosis
2. Worsening disability
3. Age 18-65
4. EDSS score 4 to 6.5
Key exclusion criteria1. Immunodulation or immunosuppressive therapy
2. Steroids or cannabinoids recently
3. Psychotic illness
4. Cognitive impairment
5. Pregnancy
Date of first enrolment01/07/2005
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Peninsula Medical School
Plymouth
PL6 8BX
United Kingdom

Sponsor information

Plymouth Hospitals NHS Trust (UK)
Hospital/treatment centre

Rm N17
ITTC Building
Tamar Science Park
Plymouth
PL6 8BX
England
United Kingdom

Phone +44 (0)1752 315 114
Email Lisa.Vickers@phnt.swest.nhs.uk
ROR logo "ROR" https://ror.org/05x3jck08

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) - G0500290

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2013 Yes No
Results article results 01/02/2015 Yes No