A Study of Sativex® for Relief of Peripheral Neuropathic Pain Associated With Allodynia.

NCT00711880 | Completed Phase 3 Results

• 1 other identifier: GWNP0101
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.

Conditions

Pain; Peripheral Neuropathy

Keywords

Pain; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)

  The neuropathic pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline.

  Day 0 to Day 42

Secondary Outcomes (15)

• Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment

  Day 0 to Day 42

• Change From Baseline in Mean Sleep Quality at the End of Treatment

  Day 7 - Day 42

• Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment

  Day 0 - Day 42

• Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment

  Day 7 and Day 42

• Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment

  Day 0 - Day 42

Study Arms (2)

Sativex

EXPERIMENTAL

Drug: Sativex®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sativex® DRUG

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Also known as: GW-1000-02

Sativex

Placebo DRUG

containing 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.

Also known as: GW-4001-01

Placebo

Eligibility Criteria

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

You may qualify if:

• Willing and able to give informed consent.
• Male or female, aged 18 years or above.
• Chronic peripheral neuropathic pain of at least six months duration.
• Presence of mechanical allodynia within the territory of the affected nerve(s).
• Evidence of sensory change in the affected nerve by simple clinical tests.
• Peripheral neuropathic pain with a severity score of four or more on at least four completed NRS during the baseline week.
• Stable dose of analgesic medication for at least two weeks leading to study entry.
• Agreement, if female and of child bearing potential or if male with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
• Have not used cannabinoids (including cannabis, Marinol or Nabilone) for at least seven days before Visit 1 and were willing to abstain from any use of cannabinoids during the study.
• Ability (in the investigator's opinion) and willingness to comply with all study requirements.
• Agreement for the UK Home Office, their primary care physician, and their consultant if appropriate, to be notified of their participation in the study.

You may not qualify if:

• History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Concomitant severe non-neuropathic pain or the presence of cancer related neuropathic pain or neuropathic pain resulting from diabetes mellitus.
• Known history of alcohol or substance abuse.
• Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
• History of epilepsy.
• If female, were pregnant or lactating, or were planning a pregnancy to occur during the course of the study.
• Significant renal or hepatic impairment.
• Elective surgery or other procedures requiring general anaesthesia scheduled to occur during the study.
• Terminal illness or were considered inappropriate for placebo medication.
• Any other significant disease or disorder which, in the opinion of the investigator, may have either put the subject at risk because of participation in the study, or may influenced the result of the study, or the subject's ability to participate in the study.
• Regular levodopa (Sinemet®, Sinement Plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®) therapy within the seven days leading to study entry.
• If male, were receiving and were unwilling to stop sildenafil (Viagra®) for the duration of the study.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
• Known or suspected adverse reaction to cannabinoids.
• Intention to travel internationally during the study.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Clinical Trials Unit, The Walton Centre

Fazakerley, Liverpool, L9 7LJ, United Kingdom

Location

Related Publications (1)

• Nurmikko TJ, Serpell MG, Hoggart B, Toomey PJ, Morlion BJ, Haines D. Sativex successfully treats neuropathic pain characterised by allodynia: a randomised, double-blind, placebo-controlled clinical trial. Pain. 2007 Dec 15;133(1-3):210-20. doi: 10.1016/j.pain.2007.08.028. Epub 2007 Nov 7.

  PMID: 17997224 RESULT

MeSH Terms

Conditions

Pain; Peripheral Nervous System Diseases

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

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

rp@gwpharm.com

0044 1223 266800

Study Officials

• Turo Nurmikko, MB BS PhD

  Clinical Trials Unit, The Walton Centre

  PRINCIPAL INVESTIGATOR

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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Study Start: May 1, 2002
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: April 12, 2023
• Results First Posted: September 28, 2012

Record last verified: 2023-04

Locations

GB (1)