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

NCT01606189 | Completed Phase 3 Results

• 1 other identifier: GWBP0101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)

  Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero "no pain at all" to 10 "pain as bad as you can imagine". The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.

  Up to 74 days

Secondary Outcomes (8)

• Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).

  Up to 74 days

• Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).

  Up to 74 days

• Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)

  Up to 74 days

• Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)

  Up to 74 days

• Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)

  Up to 74 days

Study Arms (3)

GW-1000-02

EXPERIMENTAL

Active treatment.

Drug: GW-1000-02

GW-2000-02

EXPERIMENTAL

Active treatment.

Drug: GW-2000-02

Placebo

PLACEBO COMPARATOR

Placebo control.

Drug: Placebo

Interventions

GW-1000-02 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.

Also known as: Sativex

GW-1000-02

GW-2000-02 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.

GW-2000-02

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

The Royal National Orthopaedic Hospital

Middlesex, HA7 4LP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 15561385 RESULT

MeSH Terms

Conditions

Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Pharma Ltd.

rp@gwpharm.com

0044 1223 266800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: December 1, 2001
• Primary Completion: September 1, 2002
• Study Completion: September 1, 2002
• Last Updated: January 10, 2023
• Results First Posted: November 19, 2012

Record last verified: 2022-12

Locations

GB (1)