Tags

Type your tag names separated by a space and hit enter

A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis.
Neurol Res. 2010 Jun; 32(5):451-9.NR

Abstract

BACKGROUND

Muscle spasticity is common in multiple sclerosis (MS), occurring in more than 60% of patients.

OBJECTIVE

To compare Sativex with placebo in relieving symptoms of spasticity due to MS.

METHODS

A 15-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study in 337 subjects with MS spasticity not fully relieved with current anti-spasticity therapy.

RESULTS

The primary endpoint was a spasticity 0-10 numeric rating scale (NRS). Intention-to-treat (ITT) analysis showed a non-significant improvement in NRS score, in favor of Sativex. The per protocol (PP) population (79% of subjects) change in NRS score and responder analyses (> or =30% improvement from baseline) were both significantly superior for Sativex, compared with placebo: -1.3 versus -0.8 points (change from baseline, p=0.035); and 36% versus 24% (responders, p=0.040). These were supported by the time to response (ITT: p=0.068; PP: p=0.025) analyses, carer global impression of change assessment (p=0.013) and timed 10-meter walk (p=0.042). Among the subjects who achieved a > or =30% response in spasticity with Sativex, 98, 94 and 73% reported improvements of 10, 20 and 30%, respectively, at least once during the first 4 weeks of treatment. Sativex was generally well tolerated, with most adverse events reported being mild-to-moderate in severity.

DISCUSSION AND CONCLUSIONS

The 0-10 NRS and responder PP analyses demonstrated that Sativex treatment resulted in a significant reduction in treatment-resistant spasticity, in subjects with advanced MS and severe spasticity. The response observed within the first 4 weeks of treatment appears to be a useful aid to prediction of responder/non-responder status.

Authors+Show Affiliations

Royal Berkshire and Battle Hospitals NHS Trust, London Road, Reading, Berkshire RG1 5AN, UK. christine.collin@royalberkshire.nhs.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20307378

Citation

Collin, C, et al. "A Double-blind, Randomized, Placebo-controlled, Parallel-group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis." Neurological Research, vol. 32, no. 5, 2010, pp. 451-9.
Collin C, Ehler E, Waberzinek G, et al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res. 2010;32(5):451-9.
Collin, C., Ehler, E., Waberzinek, G., Alsindi, Z., Davies, P., Powell, K., Notcutt, W., O'Leary, C., Ratcliffe, S., Nováková, I., Zapletalova, O., Piková, J., & Ambler, Z. (2010). A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurological Research, 32(5), 451-9. https://doi.org/10.1179/016164109X12590518685660
Collin C, et al. A Double-blind, Randomized, Placebo-controlled, Parallel-group Study of Sativex, in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis. Neurol Res. 2010;32(5):451-9. PubMed PMID: 20307378.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. AU - Collin,C, AU - Ehler,E, AU - Waberzinek,G, AU - Alsindi,Z, AU - Davies,P, AU - Powell,K, AU - Notcutt,W, AU - O'Leary,C, AU - Ratcliffe,S, AU - Nováková,I, AU - Zapletalova,O, AU - Piková,J, AU - Ambler,Z, Y1 - 2010/03/19/ PY - 2010/3/24/entrez PY - 2010/3/24/pubmed PY - 2010/9/30/medline SP - 451 EP - 9 JF - Neurological research JO - Neurol. Res. VL - 32 IS - 5 N2 - BACKGROUND: Muscle spasticity is common in multiple sclerosis (MS), occurring in more than 60% of patients. OBJECTIVE: To compare Sativex with placebo in relieving symptoms of spasticity due to MS. METHODS: A 15-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study in 337 subjects with MS spasticity not fully relieved with current anti-spasticity therapy. RESULTS: The primary endpoint was a spasticity 0-10 numeric rating scale (NRS). Intention-to-treat (ITT) analysis showed a non-significant improvement in NRS score, in favor of Sativex. The per protocol (PP) population (79% of subjects) change in NRS score and responder analyses (> or =30% improvement from baseline) were both significantly superior for Sativex, compared with placebo: -1.3 versus -0.8 points (change from baseline, p=0.035); and 36% versus 24% (responders, p=0.040). These were supported by the time to response (ITT: p=0.068; PP: p=0.025) analyses, carer global impression of change assessment (p=0.013) and timed 10-meter walk (p=0.042). Among the subjects who achieved a > or =30% response in spasticity with Sativex, 98, 94 and 73% reported improvements of 10, 20 and 30%, respectively, at least once during the first 4 weeks of treatment. Sativex was generally well tolerated, with most adverse events reported being mild-to-moderate in severity. DISCUSSION AND CONCLUSIONS: The 0-10 NRS and responder PP analyses demonstrated that Sativex treatment resulted in a significant reduction in treatment-resistant spasticity, in subjects with advanced MS and severe spasticity. The response observed within the first 4 weeks of treatment appears to be a useful aid to prediction of responder/non-responder status. SN - 1743-1328 UR - https://www.unboundmedicine.com/medline/citation/20307378/A_double_blind_randomized_placebo_controlled_parallel_group_study_of_Sativex_in_subjects_with_symptoms_of_spasticity_due_to_multiple_sclerosis_ L2 - http://www.tandfonline.com/doi/full/10.1179/016164109X12590518685660 DB - PRIME DP - Unbound Medicine ER -