Condition category
Signs and Symptoms
Date applied
14/11/2005
Date assigned
18/11/2005
Last edited
12/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Wright

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

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

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

Trial setting

Not specified

Trial 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

Phase

Not Applicable

Drug names

Tetrahydrocannabinol (THC), cannabidiol (CBD)

Primary outcome measures

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. 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 trial start date

13/05/2002

Overall trial end date

03/03/2004

Reason abandoned

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 Investigator’s opinion), and willing to comply with all study requirements

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

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 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 date

13/05/2002

Recruitment end date

03/03/2004

Locations

Countries of recruitment

United Kingdom

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/09/2016: No publications found, verifying study status with principal investigator.