A Study to Compare Sublingual Cannabis Based Medicine Extracts With Placebo to Treat Brachial Plexus Injury Pain

NCT ID: NCT01606189

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2002-09-30

Brief Summary

A study to compare the efficacy of two sublingual cannabinoid based medicine extracts with placebo in the treatment of chronic pain due to brachial plexus injury.

Detailed Description

This study used a three way crossover study design. Eligible patients recorded their symptoms during a one to two week baseline period, then entered a three period, double blind, randomised crossover of GW-1000-02, GW-2000-02 and placebo. Each period lasted two weeks, with no washout between periods. There were six possible treatment sequences. The primary analysis was based on Box Scale-11 pain severity scores recorded throughout the study in patient daily diary booklets. Blood samples were taken from patient-volunteers at the beginning of each period, for measurement of plasma cannabinoid concentration.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GW-1000-02

Active treatment.

Group Type: EXPERIMENTAL

GW-1000-02

Intervention Type: DRUG

Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day.

GW-2000-02

Active treatment.

Group Type: EXPERIMENTAL

GW-2000-02

Intervention Type: DRUG

Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day.

Placebo

Placebo control.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Contains peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.

Interventions

GW-1000-02

Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day.

Intervention Type: DRUG

GW-2000-02

Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day.

Intervention Type: DRUG

Placebo

Contains peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.

Intervention Type: DRUG

Other Intervention Names

Sativex

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or above.
• Brachial plexus pain, at least 18 months after the initial injury.
• Reported weekly brachial plexus pain at the required severity at Visits 1 and 2; a Box Scale-11 pain severity score of four boxes or above.
• A pattern of pain that in the Investigator's opinion had been stable during the four weeks before study entry.
• Stable regular medication during the four weeks before study entry.
• A maximum tricyclic antidepressant dose of 75 mg per day, if applicable.
• No cannabinoid use (cannabis, Marinol® or Nabilone) at least seven days before study entry or during the study.
• If sexually active; was either using effective contraception during the study and for three months thereafter or had been surgically sterilised or, if female, was post-menopausal. All patients agreed to use a barrier method of contraception in addition to their usual form of oral or depot contraception.
• Willing and able to undertake and comply with all study requirements.
• Willing and able to consider and understand the patient information leaflet and consent form and to give informed consent. Those patients unable to read or to sign the document were managed as detailed in the Declaration of Helsinki.
• Willing for his or her general practitioner, and consultant if appropriate, to be informed of study participation.
• Willing for his or her name to be notified to Home Office for participation in the study.

Exclusion Criteria

• Abuse or strong suspicion of drug abuse, including alcohol or cannabis, or in the investigator's opinion had a tendency to drug dependency or substance abuse. Patients with a history of abuse could have been included at the discretion of the investigator.
• Known or suspected adverse reaction to cannabinoids.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
• History of any type of schizophrenia, any other psychotic illness, or other significant psychiatric illness other than depression associated with chronic illness.
• Regular levodopa therapy (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®) within seven days of study entry.
• Serious cardiovascular disorder including recent angina, uncontrolled hypertension or an uncontrolled symptomatic cardiac arrhythmia.
• History of significant renal or hepatic impairment as shown in medical history or indicated by clinical laboratory results from samples.
• History of active epilepsy or convulsions.
• Nerve surgery within six months of study entry or any other surgery within two months of study entry.
• Elective surgery, other procedures requiring general anaesthesia, or a planned hospital admission that would have taken place during the study, other than a hospital admission under the care of the study investigator.
• Terminal illness.
• Pregnancy, lactation or expected non-compliance with the contraceptive measures called for by the protocol.
• Participation in any other pharmacological clinical research study in the 12 weeks before study entry.
• Planned travel outside the UK between study entry and the end of the crossover phase.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal National Orthopaedic Hospital

Middlesex, , United Kingdom

Countries

United Kingdom

References

Berman JS, Symonds C, Birch R. Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial. Pain. 2004 Dec;112(3):299-306. doi: 10.1016/j.pain.2004.09.013.

Reference Type: RESULT

PMID: 15561385 (View on PubMed)

Other Identifiers

GWBP0101

Identifier Type: -

Identifier Source: org_study_id