A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis
Condition: Detrusor Overactivity; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Urinary Bladder, Overactive; Sclerosis
Intervention: Sativex®; Placebo
Intervention description: Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L.
Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours; containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Detrusor overactivity; Multiple Sclerosis

Summary:

      The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in
      reducing the daily number of episodes on incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give informed consent.

          -  Male or female, aged 18 years or over.

          -  Diagnosed with MS and with detrusor overactivity not wholly relieved by current
             therapy.

          -  At least three incontinence episodes within five consecutive days during the baseline
             period

          -  Stable dose of anticholinergic medication for at least 14 days 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 is used during the study and
             for three months thereafter.

          -  Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least
             seven days before Visit 1 and willing to abstain from any use of cannabinoids during
             the study.

          -  Agreement for the UK Home Office, their general practitioner, and their consultant if
             appropriate, to be notified of their participation in the study.

        Exclusion Criteria:

          -  A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes
             due to MS.

          -  Using ISC.

          -  A history of schizophrenia, other psychotic illness, severe personality disorder or
             other significant psychiatric disorder other than depression associated with their
             underlying condition.

          -  A history of alcohol or substance abuse.

          -  A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other
             than well controlled atrial fibrillation), poorly controlled hypertension or severe
             heart failure.

          -  A history of epilepsy.

          -  If female, are pregnant of lactating, or are planning a pregnancy to occur during the
             course of the study.

          -  Significant renal or hepatic impairment.

          -  Elective surgery or other procedures requiring general anesthesia scheduled to occur
             during the study.

          -  Terminal illness or 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 or influence the result of the study, or the subjects ability to participate in
             the study.

          -  Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide)
             within the seven days leading up to study entry.

          -  Receiving and unwilling to stop fentanyl for the duration of the study.

          -  Known or suspected hypersensitivity to cannabinoids or any of the excipients of the
             study medications.

          -  Intention to travel internationally or to donate blood during the study.

          -  Participation in another research study in the 12 weeks leading up to study entry.

          -  Previous randomization in to this study