Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00711880
Protocol/serial number
GWNP0101
Study information
Scientific title
A double blind, randomised, placebo controlled parallel group study of cannabis based medicine extract (CBME), in the treatment of peripheral neuropathic pain characterised by allodynia
Acronym
GWNP0101
Study hypothesis
Tetrahydrocannabinol (THC):cannabidiol (CBD), 1:1 relieves peripheral neuropathic pain characterised by allodynia.
Ethics approval(s)
Ethics approval received from the local medical ethics committee
Study design
Double-blind randomised placebo-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Peripheral neuropathic pain, characterised by allodynia
Intervention
THC:CBD, 1:1 and placebo
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Tetrahydrocannabinol (THC), cannabidiol (CBD)
Primary outcome measure
Efficacy in relieving peripheral neuropathic pain after 5 weeks of treatment
Secondary outcome measures
1. Qualitative aspects of pain as reported the Neuropathic Pain Scale (NPS)
2. The physical and psychological effects of pain using measures of sleep disturbance, the Pain Disability Index (PDI) and General Health Questionnaire (GHQ-12)
3. Patients cognitive function using the Brief Repeatable Battery of Neuropsychological tests (BRB-N)
4. Patient perception of change in allodynia and pain on movement after 5 weeks of treatment
5. Tolerability of CBME using the adverse event profile, electrocardiogram (ECG), clinical laboratory tests and vital signs
Overall study start date
13/05/2002
Overall study end date
03/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient or legal representative is willing and able to give informed consent for participation in the study (if the patient is unable to read or to sign the document, consent procedures as detailed in the Declaration of Helsinki must be followed)
2. Male or Female, aged 18 years or above
3. Chronic peripheral neuropathic pain of at least 6 months duration
4. Presence of mechanical allodynia within the territory of the affected nerve(s)
5. Evidence of sensory change in the affected nerve by simple clinical tests
6. Pain with a severity score of 4 or more on at least 4 completed BS-11 scores in the baseline week
7. Stable dose of current analgesic medication for at least 2 weeks prior to study entry
8. Female patients of child bearing potential and male patients whose partner is of child bearing potential are willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
9. Willing for his or her names to be notified to the Home Office for participation in this study
10. Willing to allow his or her General Practitioner and Consultant, if appropriate, to be notified of participation in the study
11. No cannabinoid use (cannabis, Marinolâ or Nabilone) at least 7 days before Visit 1 and willing to abstain from any use of cannabis during the study
12. Able (in the Investigators opinion), and willing to comply with all study requirements
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
80
Total final enrolment
145
Participant exclusion criteria
1. History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
2. Concomitant severe non-neuropathic pain or the presence of cancer related neuropathic pain or neuropathic pain resulting from diabetes mellitus
3. Known history of alcohol or substance abuse
4. Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure
5. History of epilepsy
6. Female patient who is pregnant, lactating or planning pregnancy during the course of the study
7. Male patient who is currently receiving and unwilling to stop sildenafil (Viagra®) and unwilling to stop for the duration of the study
8. Regular levodopa therapy within 7 days of study entry
9. Significant renal or hepatic impairment
10. Known or suspected hypersensitivity to cannabinoids
11. Scheduled elective surgery or other procedures requiring general anaesthesia during the study
12. Terminal illness
13. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patients ability to participate in the study
14. Travel outside the UK planned during the study
15. Donation of blood during the study
16. Patients who have participated in another research study in the past 12 weeks
17. Patients previously randomised into this study
Recruitment start date
13/05/2002
Recruitment end date
03/03/2004
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
GW Pharma Ltd
Salisbury
SP4 0JQ
United Kingdom
Sponsor information
Organisation
GW Pharma Ltd (UK)
Sponsor details
Porton Down Science Park
Salisbury
SP4 0JQ
United Kingdom
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
GW Pharma Ltd (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 26/09/2019 | No | No | ||
| Results article | results | 15/12/2007 | 26/09/2019 | Yes | No |