Study register · detailKohortenstudie · Multiple Sclerosis · 2016
Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice.
Vermersch et al.·European neurologyImpact 1.1
Clear benefitGRADELow50 citations
Samplen = 433 Pat.
Duration3 months
EndpointSpasticity score
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
THC:CBD spray significantly improved MS-related spasticity and associated symptoms after 3 months with good tolerability.
Summary
MOVE-2 EU real-world registry, n=433 MS patients with treatment-resistant spasticity (mean duration 7,4 years, 78,1% used baclofen), prospective observation over 3 months with THC:CBD oromucosal spray as add-on therapy. After 1 month, 349 patients (responders: ≥20% spasticity improvement) continued therapy, after 3 months 281 patients. Mean dosage: 6 sprays/day. Spasticity scores and associated symptoms (spasms, fatigue, pain, sleep quality, bladder function) significantly improved, as well as activities of daily living and quality of life (EQ-5D VAS). Adverse events in 10,4% of patients, none serious.
P
PopulationAdults with multiple sclerosis and treatment-resistant spasticity, n=433 (55% female), mean MSS duration 7,4 years
OutcomeSignificant improvement in spasticity scores and associated symptoms (spasms, fatigue, pain, sleep quality, bladder dysfunction) as well as quality of life (EQ-5D VAS) after 3 months; adverse events in 10,4% (none serious)
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
Background: Tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex(R)) is an add-on therapy for moderate-to-severe multiple sclerosis (MS)-related drug-resistant spasticity (MSS).
Aim: The MOVE-2 EU study collected data from everyday clinical practice concerning the effectiveness and tolerability of THC:CBD.
Methods: This was an observational, prospective, multicentre, non-interventional study. Patients with resistant MSS prescribed add-on THC:CBD oromucosal spray according to approved labelling, were followed for 3 months. After 1 month, only responders (>/=20% improvement in spasticity) continued treatment. The main endpoints were the evolution of MSS and associated symptoms, quality of life (QoL) and tolerability.
Results: Four hundred and thirty three patients (55% female) were recruited (98% in Italy). The mean duration of MSS was 7.4 years and baclofen was used by 78.1% of participants. Three hundred and forty nine participants continued with THC:CBD oromucosal spray after 1 month, and 281 after 3 months. THC:CBD mean dosage was 6 sprays/day. MSS scores and spasticity-related symptoms (spasms, fatigue, pain, sleep quality and bladder dysfunction) were significantly improved by THC:CBD at 3 months, as were activities of daily living, and QoL (EQ-5D VAS). Adverse events, none of which were severe or serious, were reported by 10.4% of patients.
Conclusions: In everyday clinical practice, THC:CBD oromucosal spray provided symptomatic relief of MSS and related troublesome symptoms.