ECTRIMS eLearning

Effect of THC/CBD oromucosal spray on spasticity in MS: an open label clinical-neurophysiological study
Author(s):
A. Nuara
,
A. Nuara
Affiliations:
A. Giordano
,
A. Giordano
Affiliations:
L. Ferrè
,
L. Ferrè
Affiliations:
V. Martinelli
,
V. Martinelli
Affiliations:
F. Martinelli Boneschi
,
F. Martinelli Boneschi
Affiliations:
F. Esposito
,
F. Esposito
Affiliations:
G. Comi
,
G. Comi
Affiliations:
L. Leocani
L. Leocani
Affiliations:
ECTRIMS Learn. Nuara A. 09/16/16; 145778; P1094
Dr. Arturo Nuara
Dr. Arturo Nuara
Contributions
Abstract

Abstract: P1094

Type: Poster

Abstract Category: Pathology and pathogenesis of MS - Neurophysiology

Background: Spasticity, manifesting as muscle stiffness, spasms and pain, is a frequent symptom of multiple sclerosis (MS), with a strong impact on quality on life of patients. Cannabis derivatives and endocannabinoid system modulator (such as Sativex, a THC/CBD oromucosal spray) have been reported to relieve symptoms of spasticity in MS. Despite demonstrated symptomatic relief of MS spasticity, few studies have investigated neurophysiological baseline characteristics on predicting treatment response, as well as the neurophysiological changes induced by theraphy with cannabinoids in MS.

Objectives: To assess the clinical-neurophysiological correlates of Sativex effect on spasticity in MS and the predictive value of neurophysiological baseline features on treatment response.

Methods: 20 outpatients affected by multiple sclerosis (6M, 14F, age 31-64, EDSS 4.0-7.5) with spasticity-associated symptoms (baseline spasticity NRS>4) underwent the following clinical evaluations at baseline (T0) and after a 4-week (T4) Sativex titration period: EDSS, 10 meters walking test, Ambulation Index (AI), Modified Ashworth Scale (MAS), spasticity and pain numerical-rating-scale (NRS). Neurophysiological baseline features (resting motor threshold [RMT], Motor-evoked-potentials [MEP"s] amplitude of First Digital Interosseus [FDI] at 120% of RMT, intracortical inhibition/facilitation [ICI/ICF] were collected at T0 in the whole group ad in 10 patients at T4.

Results: From T0 to T4, a significant improvement of spasticity was observed, considering both subjective (NRS 7+1.45 vs 5.15+1.38, p=0.0001) and physician-reported (MAS 3.3+1.94 2.93+1.70) spasticity. No significant changes in neurophysiological measures were observed. Grouping patients according to treatment responsiveness (NRS improvement >20%, 9 responder), no significant differences were found in neurophysiological baseline features.

Conclusion: Our findings confirm the clinical benefit of Sativex on MS spasticity. The lack of both corresponding changes in corticospinal excitability and baseline neurophysiological predictors of efficacy, suggest the involvement of other neurophysiological mechanisms underlying Sativex effect on spasticity.

Disclosure: Arturo Nuara has nothing to disclose



A. Giordano has nothing to disclose



L. Ferrè has nothing to disclose



V. Martinelli has received speaker honoraria or funding for travel expenses from Biogen-Dompé SG, Merck Serono, Bayer Schering Pharma, Novartis, Teva Pharmaceutical Industries and Sanofi-Aventis



F. Martinelli-Boneschi has received personal compensation for activities with Teva CNS as a speaker and/or an advisor.



F. Esposito received honoraria from TEVA and Merck



G. Comi has received compensation for consulting services with the following companies: Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche, Almirall, Chugai, Receptos, Forward Pharma and compensation for speaking activities: Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche.



L. Leocani received personal compensation from Biogen (Advisory Board); Almirall, Novartis (travel support). Biogen (travel support ) Merck Serono (research support)



Abstract: P1094

Type: Poster

Abstract Category: Pathology and pathogenesis of MS - Neurophysiology

Background: Spasticity, manifesting as muscle stiffness, spasms and pain, is a frequent symptom of multiple sclerosis (MS), with a strong impact on quality on life of patients. Cannabis derivatives and endocannabinoid system modulator (such as Sativex, a THC/CBD oromucosal spray) have been reported to relieve symptoms of spasticity in MS. Despite demonstrated symptomatic relief of MS spasticity, few studies have investigated neurophysiological baseline characteristics on predicting treatment response, as well as the neurophysiological changes induced by theraphy with cannabinoids in MS.

Objectives: To assess the clinical-neurophysiological correlates of Sativex effect on spasticity in MS and the predictive value of neurophysiological baseline features on treatment response.

Methods: 20 outpatients affected by multiple sclerosis (6M, 14F, age 31-64, EDSS 4.0-7.5) with spasticity-associated symptoms (baseline spasticity NRS>4) underwent the following clinical evaluations at baseline (T0) and after a 4-week (T4) Sativex titration period: EDSS, 10 meters walking test, Ambulation Index (AI), Modified Ashworth Scale (MAS), spasticity and pain numerical-rating-scale (NRS). Neurophysiological baseline features (resting motor threshold [RMT], Motor-evoked-potentials [MEP"s] amplitude of First Digital Interosseus [FDI] at 120% of RMT, intracortical inhibition/facilitation [ICI/ICF] were collected at T0 in the whole group ad in 10 patients at T4.

Results: From T0 to T4, a significant improvement of spasticity was observed, considering both subjective (NRS 7+1.45 vs 5.15+1.38, p=0.0001) and physician-reported (MAS 3.3+1.94 2.93+1.70) spasticity. No significant changes in neurophysiological measures were observed. Grouping patients according to treatment responsiveness (NRS improvement >20%, 9 responder), no significant differences were found in neurophysiological baseline features.

Conclusion: Our findings confirm the clinical benefit of Sativex on MS spasticity. The lack of both corresponding changes in corticospinal excitability and baseline neurophysiological predictors of efficacy, suggest the involvement of other neurophysiological mechanisms underlying Sativex effect on spasticity.

Disclosure: Arturo Nuara has nothing to disclose



A. Giordano has nothing to disclose



L. Ferrè has nothing to disclose



V. Martinelli has received speaker honoraria or funding for travel expenses from Biogen-Dompé SG, Merck Serono, Bayer Schering Pharma, Novartis, Teva Pharmaceutical Industries and Sanofi-Aventis



F. Martinelli-Boneschi has received personal compensation for activities with Teva CNS as a speaker and/or an advisor.



F. Esposito received honoraria from TEVA and Merck



G. Comi has received compensation for consulting services with the following companies: Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche, Almirall, Chugai, Receptos, Forward Pharma and compensation for speaking activities: Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche.



L. Leocani received personal compensation from Biogen (Advisory Board); Almirall, Novartis (travel support). Biogen (travel support ) Merck Serono (research support)



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