A one year open label assessment of the use of nabilone in the treatment of chronic neuropathic pain

ISRCTN	ISRCTN38408594
DOI	https://doi.org/10.1186/ISRCTN38408594
Protocol serial number	CL0022
Sponsor	Cambridge Laboratories Ltd (UK)
Funder	Cambridge Laboratories Ltd (UK)

Submission date: 23/07/2007
Registration date: 12/09/2007
Last edited: 28/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dilip Kapur
Scientific

Flinders Medical Centre
Pain Management Centre
Bedford Park
Adelaide
5042
Australia

Phone	+61 8 82045499
Email	dilip.kapur@flinders.edu.au

Study information

Primary study design	Interventional
Study design	One year open label non-randomised uncontrolled trial
Secondary study design	Non randomised study
Scientific title	A one year open label assessment of the use of nabilone in the treatment of chronic neuropathic pain
Study objectives	The purpose of the study is to investigate the following: 1. Reported levels of pain in patients receiving nabilone for the treatment of chronic neuropathic pain for a period of one year 2. Patient tolerance of nabilone when used in the treatment of chronic neuropathic pain over a period of one year 3. Effects of nabilone on memory and psychometric function when used in the treatment of chronic neuropathic pain over a period of one year
Ethics approval(s)	1. South Tees Local Research Ethics Committee on the 26th March 2002 (ref: 00/51) 2. West Ethics Committee Glasgow on the 7th December 2001 (ref: 01/182) 3. Newcastle and North Tyneside Joint Ethics Committee on the 30th October 2001 (ref: 2000/138)
Health condition(s) or problem(s) studied	Mixed neuropathic pain
Intervention	Coming out of the cross-over trial mentioned in the inclusion criteria, patients with benefit on either of the study drugs was offered to participate in the open label trial. Nabilone capsules for oral intake were titrated in the first four weeks to 1 mg, then doubled to 2 mg if there were no side effects and then doubled again to 4 mg which was the maximum dose. The dose was then reduced to the lowest effective dose and the patient continued on this dose for one year if they did not decide to withdraw.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nabilone
Primary outcome measure(s)	Mean monthly pain scores compared to baseline: Visual Analogue Scale (VAS) scores were recorded daily in a diary together with hours slept and sleep interruption. Pain score were averaged over one month and compared to baseline every three months in the analysis.
Key secondary outcome measure(s)	1. Sleep was measured as hours slept and if the sleep was interrupted or not in the diary 2. Depression and anxiety were measured with the Hospital Anxiety and Depression Score (HAD) at baseline and then every three months 3. Depression 4. Quality of life was measured with the 36-item Short Form questionnaire (SF-36) at baseline and then every three months 5. Side effects were collected monthly with the eight-point questionnaire rating the severity of the side effects on a five point scale plus a field for open comments 6. Psychometric tests performed every three months
Completion date	01/01/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	90
Key inclusion criteria	Patients with chronic neuropathic pain who have previously participated in the trial entitled: 'A randomised, crossover, double blind comparison of the analgesic effect and patient tolerability of nabilone and dihydrocodeine in chronic neuropathic pain' (see ISRCTN15330757) may enter this study. As such, patients will already have satisfied criteria for the diagnosis of chronic neuropathic pain.
Key exclusion criteria	Patients may not enter the study if they have a history of any of the following conditions: 1. Epilepsy 2. Liver disease 3. Psychosis 4. Bipolar disorder 5. Substance misuse 6. Renal failure 7. Adverse reactions to nabilone 8. Pregnant women, lactating women or women of childbearing potential not using effective methods of contraception 9. Patients involved in ongoing legal action against a third party in which financial compensation is being sought for personal injury alleged to be the cause of the presenting condition Excluded medication: Patients may not take the following medications during the study: 1. Antipsychotic drugs 2. Benzodiazepine drugs (excepting stable doses of night-time sedatives) 3. Monoamine oxidase inhibitors Patients taking cannabinoid preparations of any kind may not be included in the study.
Date of first enrolment	01/10/2001
Date of final enrolment	01/01/2003

Locations

Countries of recruitment

United Kingdom
Australia

Study participating centre

Flinders Medical Centre

Adelaide
5042
Australia

Results and Publications

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

Editorial Notes

28/11/2019: No publications found. Verifying results with principal investigator.
02/02/2017: No publications found in PubMed, verifying study status with principal investigator.