A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.

NCT00713323 | Completed Phase 3 Results

• 1 other identifier: GWCL0404 Part A
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.

Conditions

Pain; Peripheral Neuropathy

Keywords

Pain; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment

  The average pain NRS was complete 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.

  38 weeks

Secondary Outcomes (7)

• Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)

  38 weeks

• Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)

  38 weeks

• Subject Global Impression of Change

  week 38

• Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment

  38 weeks

• Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment

  38 weeks

Study Arms (1)

Sativex

EXPERIMENTAL

Active treatment

Drug: Sativex®

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

Eligibility Criteria

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

You may qualify if:

• Had participated in a GW clinical study to investigate the effects of Sativex® on peripheral neuropathic pain and had completed the study. This must have been within the last seven days
• Had complied with all of the study requirements in the preceding GW parent RCTs, including the completion of diary cards and study questionnaires
• Had shown tolerability to the study medication in a preceding GW study
• Was expected, in the opinion of the investigator, to gain clinical benefit from receiving Sativex® therapy
• Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires
• 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:

• 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 five minutes prior to measurement at Visit 1
• 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
• Female subjects of child bearing potential and male subjects whose partner was of child bearing potential, unless they were willing to ensure that they or their partner used effective contraception during the study and for three months thereafter
• If female, were pregnant or lactating, or were planning pregnancy during the course of the study and for three months thereafter
• Received an IMP within the 12 weeks before Visit 1 (except the prerequisite study medication from the GW parent RCTs)
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study or the subject's ability to participate in the study
• Following a physical examination, the subject had any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital

Solihull, West Midlands, B91 2JL,, United Kingdom

Location

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

• Barbara Hoggart, MBBS, FRCA

  Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 11, 2008
• Study Start: October 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 3, 2023
• Results First Posted: September 14, 2012

Record last verified: 2023-04

Locations

GB (1)