←Multiple Sclerosis
Study register · detail RCT (Phase III) · Multiple Sclerosis · 2013

A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis

Langford et al. ·Journal of Neurology Impact 4.2
Mixed GRADE High 296 citations
Samplen = 339 Pat.
Duration14 weeks
ControlPlacebo spray as add-on
EndpointResponder analysis 30%
Blindingdoppelblind
DesignRCT (Phase III)
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
Key finding

Primary endpoint in Phase A not met (50% vs. 45% responders, p=0,234), but significant effects in Phase B with improved time to treatment failure and significant improvements in pain and sleep quality scores in favor of THC/CBD.

Summary

n=339 MS patients with central neuropathic pain, THC/CBD spray (Sativex) as add-on vs. placebo over 14 weeks; primary endpoint (≥30% responders, week 14) missed (50% THC/CBD vs. 45% placebo, p=0.234), but significant at week 10 (p=0.046). Randomized withdrawal phase: time to treatment failure significantly in favor of THC/CBD (24% vs. 57% placebo, p=0.04); pain reduction (NRS p=0.028) and sleep quality (p=0.015) significantly improved.

P
PopulationAdults with central neuropathic pain in multiple sclerosis, insufficient response to existing analgesia, n=339
I
InterventionTHC/CBD oromucosal spray (nabiximols/Sativex) as add-on, 14 weeks (Phase A) + 18-week randomized withdrawal phase (Phase B)
C
ControlPlacebo spray as add-on
O
OutcomePrimary endpoint Phase A (30% responder analysis week 14) not met: 50% responders THC/CBD vs. 45% placebo (p=0,234); Phase B primary endpoint (time to treatment failure) significantly in favor of THC/CBD: 24% vs. 57% failures (p=0,04)
Confidence in the evidence
High

The highest of four GRADE levels, the effect estimate is very reliable.

Quality profile
Sample size ★★★★★
Blinding Double-blind
Effect size Mixed
Citations / year ★★★★★
Authors
Langford R M, Mares J, Novotna A et al.
DOI 10.1007/s00415-012-6739-4↗
Design: RCT (Phase III)
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Indication
Further studies on Multiple Sclerosis
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The impediment to action advances action. — Marcus Aurelius