Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Neuralgia; Sclerosis
Intervention: Sativex; Placebo
Intervention description: Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.
Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg.; Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 339.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Central Neuropathic Pain

Summary:

      The purpose of this study is to find out if cannabis-based medicine compared to a dummy
      medicine (placebo that contains no active ingredient) can help the central neuropathic pain
      patients experience as a result of multiple sclerosis. This type of pain "central neuropathic
      pain" is described as shooting, stabbing, burning or searing like sensation, which is often
      worse at night.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any disease sub-type of MS of at least two years duration

          -  Central neuropathic pain (CNP) of at least three months and expected to remain stable
             for the study duration

          -  Moderate CNP defined by NRS pain score at baseline sum to at least 24

          -  Subject established on or previously tried and failed analgesic therapy for CNP

          -  If receiving disease modifying medications, stable dose for 3 months and maintained
             for study duration

        Exclusion Criteria:

          -  Subjects whose identified pain is likely to be nociceptive, musculoskeletal (including
             spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal
             neuralgia.

          -  Other non central neuropathic pain of a severity which is likely to interfere with the
             patients assessment of CNP

          -  medical history suggests subject is likely to relapse/remit during course of study

          -  history of schizophrenia (including family history), other psychotic illness, severe
             personality disorder or other significant psychiatric disorder other than depression
             associated with MS

          -  known or suspected history of alcohol abuse, epilepsy or recurrent seizures or
             hypersensitivity to cannabinoids

          -  travel outside of the country of residence planned during the study

          -  significant cardiac, renal or hepatic impairment

          -  subjects with current recreational cannabis, medicinal cannabis or synthetic
             cannabinoid based medications within 3 months prior to study entry and unwilling to
             abstain for the duration of the study