Clinical Studies and Case Reports

On this site you will find clinical studies with cannabis or single cannabinoids in different diseases and case reports on the use of cannabis by patients.
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TitleEffect of dronabinol on progression in progressive multiple sclerosis (CUPID): a randomised, placebo-controlled trial.
Author(s)Zajicek J, Ball S, Wright D, Vickery J, Nunn A, Miller D, Cano MG, McManus D, Mallik S, Hobart J; on behalf of the CUPID investigator group.
Journal, Volume, IssueLancet Neurol. 2013 Sep;12(9):857-65.
Major outcome(s)THC, which was given for 36 months, had no effect on progression compared to placebo
IndicationMultiple sclerosis;SpasticityAbstract
MedicationDelta-9-THC

BACKGROUND: Laboratory evidence has shown that cannabinoids might have a
neuroprotective action. We investigated whether oral dronabinol
(Δ(9)-tetrahydrocannabinol) might slow the course of progressive multiple
sclerosis.
METHODS: In this multicentre, parallel, randomised, double-blind,
placebo-controlled study, we recruited patients aged 18-65 years with primary or
secondary progressive multiple sclerosis from 27 UK neurology or rehabilitation
departments. Patients were randomly assigned (2:1) to receive dronabinol or
placebo for 36 months; randomisation was by stochastic minimisation, using a
computer-generated randomisation sequence, balanced according to expanded
disability status scale (EDSS) score, centre, and disease type. Maximum dose was
28 mg per day, titrated against bodyweight and adverse effects. Primary outcomes
were EDSS score progression (masked assessor, time to progression of ≥1 point
from a baseline score of 4·0-5·0 or ≥0·5 points from a baseline score of ≥5·5,
confirmed after 6 months) and change from baseline in the physical impact
subscale of the 29-item multiple sclerosis impact scale (MSIS-29-PHYS). All
patients who received at least one dose of study drug were included in the
intention-to-treat analyses. This trial is registered as an International
Standard Randomised Controlled Trial (ISRCTN 62942668).
FINDINGS: Of the 498 patients randomly assigned to a treatment group, 329
received at least one dose of dronabinol and 164 received at least one dose of
placebo (five did not receive the allocated intervention). 145 patients in the
dronabinol group had EDSS score progression (0·24 first progression events per
patient-year; crude rate) compared with 73 in the placebo group (0·23 first
progression events per patient-year; crude rate); HR for prespecified primary
analysis was 0·92 (95% CI 0·68-1·23; p=0·57). Mean yearly change in MSIS-29-PHYS
score was 0·62 points (SD 3·29) in the dronabinol group versus 1·03 points (3·74)
in the placebo group. Primary analysis with a multilevel model gave an estimated
between-group difference (dronabinol-placebo) of -0·9 points (95% CI -2·0 to
0·2). We noted no serious safety concerns (114 [35%] patients in the dronabinol
group had at least one serious adverse event, compared with 46 [28%] in the
placebo group).
INTERPRETATION: Our results show that dronabinol has no overall effect on the
progression of multiple sclerosis in the progressive phase. The findings have
implications for the design of future studies of progressive multiple sclerosis,
because lower than expected progression rates might have affected our ability to
detect clinical change.
FUNDING: UK Medical Research Council, National Institute for Health Research
Efficacy and Mechanism Evaluation programme, Multiple Sclerosis Society, and
Multiple Sclerosis Trust.

Route(s)Oral
Dose(s)
Duration (days)1000
Participants498 patients suffering from progressive multiple sclerosis
DesignControlled study
Type of publicationMedical journal
Address of author(s)Peninsula Clinical Trials Unit, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK. Electronic address: john.zajicek@nhs.net.
Full texthttp://www.sciencedirect.com/science/article/pii/S1474442213701595

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