Condition category
Nervous System Diseases
Date applied
03/05/2005
Date assigned
21/06/2005
Last edited
13/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.pms.ac.uk/cnrg/cupid

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 measures

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23856559
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25676540

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes