Study register · detailRCT · Multiple Sclerosis · 2016
Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity.
Haupts et al.·European neurologyImpact 1.1
Clear benefitGRADEHigh30 citations
Samplen = 241 Pat.
Durationunclear
ControlPlacebo
EndpointNRS
Blindingdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
THC:CBD spray showed significantly greater improvement in spasticity compared to placebo across all subgroups, independent of previous failed treatment attempts.
Summary
Post-hoc analysis of an enriched-design RCT (n=241 ITT) of THC:CBD spray vs. placebo in MS spasticity. In both subgroups (Group 1: n=162 with ≥1 failed prior therapy; Group 2: n=57 with ≥2 failed prior therapies), response on the NRS 0-10 was significantly greater under THC:CBD than placebo — both for MCID (≥18% improvement vs. baseline) and CID (≥30% improvement). Tolerability was independent of prior therapy history.
P
PopulationAdults with moderate to severe MS spasticity, subgroup analysis: Group 1 (≥1 failed pretreatment with baclofen or tizanidine, n=162) and Group 2 (≥2 failed pretreatments with both, n=57); ITT population n=241
I
InterventionTHC:CBD oromucosal spray (Sativex) as add-on therapy
C
ControlPlacebo (oromucosal spray)
O
OutcomeSpasticity NRS response (MCID ≥18% and CID ≥30% improvement vs. baseline) significantly greater under THC:CBD vs. placebo in all subgroups; sleep quality and walking speed (Timed 10-Meter Walk) also improved, independent of number of failed prior therapies
Confidence in the evidence
Very lowLowModerateHigh
High
The highest of four GRADE levels, the effect estimate is very reliable.
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeClear benefit
Citations / year★★★★★
Authors
Haupts M, Vila C, Jonas A, Witte K, Alvarez-Ossorio L
Background: Sativex(R) (THC:CBD oromucosal spray) is indicated as add-on treatment for patients with moderate to severe multiple sclerosis (MS) spasticity. We aimed to determine whether antispasticity treatment history influenced the efficacy and safety of add-on THC:CBD oromucosal spray in MS spasticity patients.
Methods: Post hoc analysis of an enriched-design clinical trial of THC:CBD oromucosal spray versus placebo, using records of patients under previous and current ineffective antispasticity therapies. Subgroups were patients with at least 1 failed therapy attempt with either baclofen or tizanidine (Group 1) or at least 2 failed therapy attempts with both baclofen and tizanidine (Group 2).
Summary: Of 241 patients in the intent-to-treat population, 162 and 57 patients met the criteria for Groups 1 and 2, respectively. In all groups, response on the spasticity 0-10 Numerical Rating Scale was significantly greater with THC:CBD oromucosal spray versus placebo, for minimal clinically important difference (MCID >/=18% improvement vs. baseline) and clinically important difference (CID, >/=30% improvement vs. baseline). THC:CBD oromucosal spray improved spasticity-related symptoms such as sleep quality and timed 10-meter walk independent of the number of prior failed therapy attempts. Tolerability was not influenced by pre-treatment history.
Conclusions: THC:CBD oromucosal spray provided consistent relief with good tolerability in MS spasticity patients irrespective of their antispasticity pre-treatment history.