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

Abstract

Pain was significantly reduced when measured directly after administration of ECP002A in the clinic but not when measured in a daily diary. A similar pattern was observed in subjective muscle spasticity. Other clinical outcomes were not significantly different between active treatment and placebo. Cognitive testing indicated that there was no decline in cognition after 2 or 4 weeks of treatment attributable to ECP002A compared with placebo. Implications This study specifically underlines the added value of thorough investigation of pharmacokinetic and pharmacodynamic associations in the target population. Despite the complex interplay of psychoactive effects and analgesia, the current oral formulation of Δ9-tetrahydrocannabinol may play a role in the treatment of spasticity and pain associated with MS because it was well tolerated and had a stable pharmacokinetic profile.

Italian consensus on treatment of spasticity in multiple sclerosis

“…There were 13 full text articles that met the inclusion criteria for the GRADE analysis, from which five outcomes were evaluated (AS, MAS, spasticity NRS, MSSS‐88 and spasticity VAS). The AS was assessed in five randomized, placebo‐controlled, double‐blind parallel group studies , the MAS was evaluated in a further five, placebo‐controlled randomized controlled trials , six placebo‐controlled randomized controlled trials assessed the spasticity NRS as an outcome , two multicentre, placebo‐controlled, randomized controlled trials used the MSSS‐88 as an outcome , and the spasticity VAS was the primary outcome in one randomized double‐blind placebo‐controlled study of 6 weeks’ duration …”

“…There were 13 full text articles that met the inclusion criteria for the GRADE analysis, from which five outcomes were evaluated (AS, MAS, spasticity NRS, MSSS-88 and spasticity VAS). The AS was assessed in five randomized, placebo-controlled, double-blind parallel group studies [21][22][23][24][25][26], the MAS was evaluated in a further five, placebo-controlled randomized controlled trials [27][28][29][30][31], six placebo-controlled randomized controlled trials assessed the spasticity NRS as an outcome [21,23,[27][28][29][30], two multicentre, placebo-controlled, randomized controlled trials used the MSSS-88 as an outcome [32,33], and the spasticity VAS was the primary outcome in one randomized double-blind placebo-controlled study of 6 weeks' duration [31] Quality of the evidence and recommendation The panel agreed that evidence exists to recommend cannabinoids, and particularly oromucosal spray nabiximols, for the treatment of spasticity in MS patients; the strength of the recommendation was strong.…”

Spastiškumo sąsajos su neuropatiniu skausmu pacientams, sergantiems išsėtine skleroze

“…Vie ni au to riai tei gia, kad jø at lik ta me ty ri me pa cien tai, ku rie skun dë si di des nio laips nio spas tið ku mu, skun dë si ir di des niu skaus mu [14]. Ki to at lik to ty ri mo au to riai tei gia, kad pa cien tams, ku riems bu vo efek ty vus spas tið ku mo gydy mas, taip pat su ma þë jo ir skaus mas [12,18]. Li te ra tû ros duo me ni mis, spas tið ku mas ga li su kel ti skaus mà.…”

“…Li te ra tû ros duo me ni mis, spas tið ku mas ga li su kel ti skaus mà. Ðià hi pote zae áro dë ir mû sø at lik tas ty ri mas: neu ro pa ti nis skaus mas bu vo ste bi mas to se pa èio se ga lû në se, kur bu vo nu sta ty tas spas tið ku mas [14,[16][17][18]. Ðiai hi po te zei (spas tið ku mas turi áta kos neu ro pa ti niui skaus mui at si ras ti) pa tvir tin ti rei këtø dau giau ið nag ri në ti spas tið ku mo ir neu ro pa ti nio skausmo at si ra di mo me cha niz mus, la biau ið si aið kin ti, ka da at sira do spas tið ku mas ir ka da -skaus mas, ka d bû tø ga li ma pati ki miau pa tvir tin ti ar pa neig ti ðià sà sa jà.…”

“…Ðiai hi po te zei (spas tið ku mas turi áta kos neu ro pa ti niui skaus mui at si ras ti) pa tvir tin ti rei këtø dau giau ið nag ri në ti spas tið ku mo ir neu ro pa ti nio skausmo at si ra di mo me cha niz mus, la biau ið si aið kin ti, ka da at sira do spas tið ku mas ir ka da -skaus mas, ka d bû tø ga li ma pati ki miau pa tvir tin ti ar pa neig ti ðià sà sa jà. S. R. An dre sen, F. Bie ring-Søren sen ir ki ti at lik to ty ri mo au to riai tei gia, kad tarp spa tið ku mo ir neu ro pa ti nio skaus mo yra ry ðys, todël la bai svar bu at lik ti dau giau ty ri mø ðia te ma [18].…”