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

ISRCTN ISRCTN38250575
DOI https://doi.org/10.1186/ISRCTN38250575
ClinicalTrials.gov number NCT00711880
Secondary identifying numbers GWNP0101
Submission date
14/11/2005
Registration date
18/11/2005
Last edited
26/09/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Stephen Wright
Scientific

GW Pharma Ltd
Porton Down Science Park
Salisbury
SP4 0JQ
United Kingdom

Study information

Study designDouble-blind randomised placebo-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA double blind, randomised, placebo controlled parallel group study of cannabis based medicine extract (CBME), in the treatment of peripheral neuropathic pain characterised by allodynia
Study acronymGWNP0101
Study hypothesisTetrahydrocannabinol (THC):cannabidiol (CBD), 1:1 relieves peripheral neuropathic pain characterised by allodynia.
Ethics approval(s)Ethics approval received from the local medical ethics committee
ConditionPeripheral neuropathic pain, characterised by allodynia
InterventionTHC:CBD, 1:1 and placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Tetrahydrocannabinol (THC), cannabidiol (CBD)
Primary outcome measureEfficacy in relieving peripheral neuropathic pain after 5 weeks of treatment
Secondary outcome measures1. 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. Patient’s 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 date13/05/2002
Overall study end date03/03/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Total final enrolment145
Participant inclusion criteria1. 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 Investigator’s opinion), and willing to comply with all study requirements
Participant exclusion criteria1. 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 patient’s 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 date13/05/2002
Recruitment end date03/03/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

GW Pharma Ltd
Salisbury
SP4 0JQ
United Kingdom

Sponsor information

GW Pharma Ltd (UK)
Industry

Porton Down Science Park
Salisbury
SP4 0JQ
United Kingdom

ROR logo "ROR" https://ror.org/01gtctx88

Funders

Funder type

Industry

GW Pharma Ltd (UK)

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?
Basic results 26/09/2019 No No
Results article results 15/12/2007 26/09/2019 Yes No

Editorial Notes

26/09/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. ClinicalTrials.gov number added.
4. Added ClinicalTrials.gov link to basic results (scientific).
12/09/2016: No publications found, verifying study status with principal investigator.