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Drug-resistant MS spasticity treatment with Sativex(®) add-on and driving ability.
Acta Neurol Scand. 2015 Jan; 131(1):9-16.AN

Abstract

OBJECTIVE

The aim of the present observational study was to determine the effects of a delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) oromucosal spray (Sativex(®) spray), brand name Sativex(®), indicated for drug-resistant MS spasticity, on the driving ability of treated MS patients.

METHODS

The study was conducted over a period of 4-6 weeks. Thirty-three MS patients with moderate to severe treatment-resistant spasticity and planned to begin add-on treatment with Sativex(®) were enrolled at three specialized MS centres in Germany. A set of five driving test procedures from a validated computerized test battery was used to evaluate the driving ability of eligible patients. Tests were performed by patients at baseline and repeated after 4-6 weeks of treatment with Sativex(®) oromucosal spray. According to German normative data, the test thresholds achieved by the general population served as a reference to allow for a fitness/unfitness to drive classification.

RESULTS

Patients showed comparable driving test results at baseline and at final visits. Only two patients changed classification shifting from 'unfit' to drive to 'fit' and vice versa. The mean severity of spasticity, as self-reported by the patients, improved with statistical significance. Sativex(®) was generally well tolerated.

CONCLUSIONS

Treatment of MS patients with Sativex(®) does not negatively impact on driving ability and may improve moderate to severe treatment-resistant MS spasticity.

Authors+Show Affiliations

NTD Study Group, NeuroPraxis - MS-Zentrum, Kaltenkirchen/Holstein, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25208898

Citation

Freidel, M, et al. "Drug-resistant MS Spasticity Treatment With Sativex(®) Add-on and Driving Ability." Acta Neurologica Scandinavica, vol. 131, no. 1, 2015, pp. 9-16.
Freidel M, Tiel-Wilck K, Schreiber H, et al. Drug-resistant MS spasticity treatment with Sativex(®) add-on and driving ability. Acta Neurol Scand. 2015;131(1):9-16.
Freidel, M., Tiel-Wilck, K., Schreiber, H., Prechtl, A., Essner, U., & Lang, M. (2015). Drug-resistant MS spasticity treatment with Sativex(®) add-on and driving ability. Acta Neurologica Scandinavica, 131(1), 9-16. https://doi.org/10.1111/ane.12287
Freidel M, et al. Drug-resistant MS Spasticity Treatment With Sativex(®) Add-on and Driving Ability. Acta Neurol Scand. 2015;131(1):9-16. PubMed PMID: 25208898.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Drug-resistant MS spasticity treatment with Sativex(®) add-on and driving ability. AU - Freidel,M, AU - Tiel-Wilck,K, AU - Schreiber,H, AU - Prechtl,A, AU - Essner,U, AU - Lang,M, Y1 - 2014/09/11/ PY - 2014/07/10/accepted PY - 2014/9/12/entrez PY - 2014/9/12/pubmed PY - 2015/6/13/medline KW - MS spasticity KW - computerized test battery KW - driving ability KW - tetrahydrocannabinol/cannabidiol SP - 9 EP - 16 JF - Acta neurologica Scandinavica JO - Acta Neurol. Scand. VL - 131 IS - 1 N2 - OBJECTIVE: The aim of the present observational study was to determine the effects of a delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) oromucosal spray (Sativex(®) spray), brand name Sativex(®), indicated for drug-resistant MS spasticity, on the driving ability of treated MS patients. METHODS: The study was conducted over a period of 4-6 weeks. Thirty-three MS patients with moderate to severe treatment-resistant spasticity and planned to begin add-on treatment with Sativex(®) were enrolled at three specialized MS centres in Germany. A set of five driving test procedures from a validated computerized test battery was used to evaluate the driving ability of eligible patients. Tests were performed by patients at baseline and repeated after 4-6 weeks of treatment with Sativex(®) oromucosal spray. According to German normative data, the test thresholds achieved by the general population served as a reference to allow for a fitness/unfitness to drive classification. RESULTS: Patients showed comparable driving test results at baseline and at final visits. Only two patients changed classification shifting from 'unfit' to drive to 'fit' and vice versa. The mean severity of spasticity, as self-reported by the patients, improved with statistical significance. Sativex(®) was generally well tolerated. CONCLUSIONS: Treatment of MS patients with Sativex(®) does not negatively impact on driving ability and may improve moderate to severe treatment-resistant MS spasticity. SN - 1600-0404 UR - https://www.unboundmedicine.com/medline/citation/25208898/Drug_resistant_MS_spasticity_treatment_with_Sativex_®__add_on_and_driving_ability_ L2 - https://doi.org/10.1111/ane.12287 DB - PRIME DP - Unbound Medicine ER -