Effects on Spasticity and Neuropathic Pain of an Oral Formulation of Δ9-tetrahydrocannabinol in Patients With Progressive Multiple Sclerosis

van Amerongen et al. ·Clinical Therapeutics Impact 2.1

Mixed GRADE Moderate 83 citations

Samplen = 24 Pat.

Duration4 weeks

ControlPlacebo

EndpointSpasticity and neuropathic…

Blindingdoppelblind

DesignRCT (crossover + parallel)

Cannabinoidthc

Routeoral

Key finding

Pain and spasticity were significantly reduced immediately after administration in the clinic setting, but not in daily self-measurement; other clinical endpoints did not differ significantly from placebo.

Summary

n=24 progressive MS with moderate spasticity, oral THC (ECP002A) vs. placebo over 4 weeks; pain reduction significant directly after clinic administration (not in the diary), similar pattern for subjective spasticity. No cognitive deterioration after 2 or 4 weeks vs. placebo.

PopulationAdults with progressive multiple sclerosis and moderate spasticity, n=24

InterventionOral Δ9-tetrahydrocannabinol (ECP002A), crossover dose-finding phase + 4-week parallel treatment phase

ControlPlacebo (parallel randomised controlled treatment phase)

OutcomePain significantly reduced directly after clinic administration; no significant effect in the diary; subjective spasticity similar pattern; other clinical endpoints not significantly different; no cognitive impairment vs. placebo

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size Mixed

Citations / year ★★★★★

Authors

van Amerongen G, Kanhai K, Baakman A C et al.

DOI 10.1016/j.clinthera.2017.01.016↗

Design: RCT (crossover + parallel)

The impediment to action advances action. — Marcus Aurelius