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

NCT00710554 | Completed Phase 3 Results

• 1 other identifier: GWCL0405
• Study Type: interventional
• Target: 246
• 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; Allodynia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)

  The peripheral neuropathic pain NRS 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 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.

  Day 7 to Day 98

Secondary Outcomes (10)

• Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)

  Day 7 to Day 98

• Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)

  Day 7 to Day 98

• Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)

  Day 7 and Day 98

• Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)

  Day 7 and Day 98

• Subject Global Impression of Change

  Day 98

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.
• Ability (in the investigators opinion) and willingness to comply with all study requirements.
• Diagnosed with PNP of at least six months duration and in who pain is not wholly relieved with their current therapy.
• Presence of mechanical allodynia within the territory of the affected nerve(s) which has been confirmed by either a positive response to stroking the allodynic area with a SENSELABTM Brush 05 or to force applied by a 5.07 gram Semmes-Weinstein monofilament.
• Had at least one of the following underlying conditions, which caused their peripheral neuropathic pain; post herpetic neuralgia, peripheral neuropathy, focal nerve lesion, radiculopathy or Complex Regional Pain Syndrome (CRPS) type 2.
• The daily diary 0-10 NRS pain scores on days B2 - B7 of the baseline period were completed and summed to at least 24.
• Stable dose of regular pain medication and non-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willingness for these to be maintained throughout the study. Where subjects were taking a medication containing paracetamol further instructions were provided, refer to Section 9.4.7.
• In the opinion of the investigator the subject has received or was currently receiving the appropriate PNP treatments for their condition.
• Agreement for the responsible authorities (as applicable in individual countries), their primary care physician, and their consultant, if appropriate, to be notified of their participation in the study.

You may not qualify if:

• Concomitant pain thought by the investigator to be of a nature or severity to interfere with the subject's assessment of their PNP.
• Receiving a prohibited medication and were unwilling to stop or comply for the duration of the study.
• Had CRPS type 1, cancer related neuropathic pain or neuropathic pain resulted from diabetes mellitus.
• Has used either cannabis (either for recreational or medical purposes) or cannabis based medications within the last year and were unwilling to abstain for the duration for the study.
• History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Known or suspected history of alcohol or substance abuse.
• History of epilepsy or recurrent seizures.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
• Evidence of cardiomyopathy.
• Experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction.
• QT interval; of \> 450 ms (males) or \> 470 ms (females) at Visit 1.
• Secondary or tertiary AV block or sinus bradycardia (HR \<50bpm unless physiological) or sinus tachycardia (HR\>110bpm) at Visit 1.
• Diastolic blood pressure of \<50 mmHg or \>105 mmHg in a sitting position at rest for 5 minutes prior to randomisation.
• Impaired renal function i.e., creatinine clearance is lower than 50ml/min at Visit 1 and is indicative of renal impairment.
• Significantly impaired hepatic function, at Visit 1, in the Investigator's opinion.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Pain Clinic Office, Gartnavel General Hospital,

Glasgow, West Lothain, G12 0YN, United Kingdom

Location

Related Publications (1)

• Serpell M, Ratcliffe S, Hovorka J, Schofield M, Taylor L, Lauder H, Ehler E. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. Eur J Pain. 2014 Aug;18(7):999-1012. doi: 10.1002/j.1532-2149.2013.00445.x. Epub 2014 Jan 13.

  PMID: 24420962 RESULT

MeSH Terms

Conditions

Pain; Peripheral Nervous System Diseases; Hyperalgesia

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

rp@gwpharm.com

0044 1223 266800

Study Officials

• Mick Serpell, MB ChB, FRCA

  Pain Clinic Office

  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 3, 2008
• First Posted: July 4, 2008
• Study Start: August 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 3, 2023
• Results First Posted: September 14, 2012

Record last verified: 2023-04

Locations

GB (1)