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 (NCT)	NCT00711880
Protocol serial number	GWNP0101
Sponsor	GW Pharma Ltd (UK)
Funder	GW Pharma Ltd (UK)

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 of protocol

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

Primary study design	Interventional
Study design	Double-blind randomised placebo-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	GWNP0101
Study objectives	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
Health condition(s) or problem(s) studied	Peripheral neuropathic pain, characterised by allodynia
Intervention	THC:CBD, 1:1 and placebo
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Tetrahydrocannabinol (THC), cannabidiol (CBD)
Primary outcome measure(s)	Efficacy in relieving peripheral neuropathic pain after 5 weeks of treatment
Key secondary outcome measure(s)	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
Completion date	03/03/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Total final enrolment	145
Key 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
Key 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
Date of first enrolment	13/05/2002
Date of final enrolment	03/03/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

GW Pharma Ltd

Salisbury
SP4 0JQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/12/2007	26/09/2019	Yes	No
Basic results			26/09/2019	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.