A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.
Condition: Pain; Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Intervention: Sativex®
Intervention description: 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
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 380.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Peripheral Neuropathy

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.

          -  Intention to donate blood during the study

          -  Previous randomisation into this study