Study register · detailRCT (Phase III, multizentrisch, placebo-kontrolliert) · Chronic Pain · 2025
Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial
Karst et al.·Nature MedicineImpact 27.6
Clear benefitGRADEModerate13 citations
Samplen = 820 Pat.
Duration12 weeks
ControlPlacebo
EndpointNRS
Blindingdoppelblind
DesignRCT (Phase III, multizentrisch, placebo-kontrolliert)
Cannabinoidvollspektrum
Routeoral
”Key finding
VER-01 significantly reduced pain intensity by 0,6 NRS points more than placebo (p<0,001) and also showed benefits for neuropathic pain (NPSI reduction 7,3 points more than placebo, p=0,017); primary endpoint met.
Summary
Phase III RCT, n=820 adults with chronic low back pain (CLBP); VER-01 (cannabis full-spectrum extract) vs. placebo over 12 weeks. Primary endpoint met: mean NRS pain reduction -1,9 points (MD vs. placebo -0,6; 95%-CI -0,9 to -0,3; p<0,001). Key secondary endpoint (neuropathic pain component): NPSI -14,4 points (MD vs. placebo -7,3; 95%-CI -13,2 to -1,3; p=0,017). Effects maintained in 6-month open-label extension (NRS -2,9); no signal of dependence.
P
PopulationAdults with chronic low back pain (CLBP), n=820 (VER-01 n=394; placebo n=426)
OutcomePhase A: NRS pain reduction MD=-0,6 (95%-CI=-0,9 to -0,3; p<0,001); NPSI reduction MD=-7,3 (95%-CI=-13,2 to -1,3; p=0,017); Phase D: no significant result for time to treatment failure (HR=0,75; p=0,288)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Design: RCT (Phase III, multizentrisch, placebo-kontrolliert)
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Abstract
Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments offer limited efficacy and carry substantial risks, warranting the development of safe and effective alternatives. This multicenter, randomized, placebo-controlled phase 3 trial evaluated the efficacy and safety of VER-01 in CLBP. It enrolled 820 adults with CLBP (VER-01, n=394; placebo, n=426) and included a double-blind 12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D). The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total neuropathic pain symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT>18). The primary endpoint for phase D was time to treatment failure. The study met its primary endpoint in phase A, with a mean pain reduction of -1.9 NRS points in the VER-01 group (mean difference (MD) versus placebo=-0.6, 95% confidence interval (CI)=-0.9 to -0.3; P<0.001). Pain further decreased to -2.9 NRS points in phase B, with effects sustained through phase C. The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of -14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo=-7.3, 95% CI=-13.2 to -1.3; P=0.017). Although phase D did not meet its primary endpoint (hazard ratio=0.75, 95% CI=0.44-1.27; P=0.288), pain increased significantly more with placebo upon withdrawal (MD=0.5, 95% CI=0.0-1.0; P=0.034). In phase A, the incidence of adverse events-mostly mild to moderate and transient-was higher with VER-01 than with placebo (83.3% versus 67.3%; P<0.001). VER-01 was well-tolerated, with no signs of dependence or withdrawal. VER-01 shows potential as a new, safe and effective treatment for CLBP.