PMID- 25208898
DCOM- 20150611
LR  - 20171116
IS  - 1600-0404 (Electronic)
IS  - 0001-6314 (Linking)
VI  - 131
IP  - 1
DP  - 2015 Jan
TI  - Drug-resistant MS spasticity treatment with Sativex((R)) add-on and driving
PG  - 9-16
LID - 10.1111/ane.12287 [doi]
AB  - 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((R)) spray), brand name Sativex((R)), 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((R)) 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((R)) 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((R)) was generally well tolerated. CONCLUSIONS:
      Treatment of MS patients with Sativex((R)) does not negatively impact on driving 
      ability and may improve moderate to severe treatment-resistant MS spasticity.
CI  - (c) 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
FAU - Freidel, M
AU  - Freidel M
AD  - NTD Study Group, NeuroPraxis - MS-Zentrum, Kaltenkirchen/Holstein, Germany.
FAU - Tiel-Wilck, K
AU  - Tiel-Wilck K
FAU - Schreiber, H
AU  - Schreiber H
FAU - Prechtl, A
AU  - Prechtl A
FAU - Essner, U
AU  - Essner U
FAU - Lang, M
AU  - Lang M
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140911
PL  - Denmark
TA  - Acta Neurol Scand
JT  - Acta neurologica Scandinavica
JID - 0370336
RN  - 0 (Drug Combinations)
RN  - 0 (Plant Extracts)
RN  - 19GBJ60SN5 (Cannabidiol)
RN  - 7J8897W37S (Dronabinol)
RN  - K4H93P747O (nabiximols)
SB  - IM
MH  - Adult
MH  - *Automobile Driving
MH  - Cannabidiol
MH  - Dronabinol
MH  - Drug Combinations
MH  - Female
MH  - Germany
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/complications/*drug therapy
MH  - Muscle Spasticity/*drug therapy/etiology
MH  - Pilot Projects
MH  - Plant Extracts/*therapeutic use
OT  - MS spasticity
OT  - computerized test battery
OT  - driving ability
OT  - tetrahydrocannabinol/cannabidiol
EDAT- 2014/09/12 06:00
MHDA- 2015/06/13 06:00
CRDT- 2014/09/12 06:00
PHST- 2014/07/10 00:00 [accepted]
PHST- 2014/09/12 06:00 [entrez]
PHST- 2014/09/12 06:00 [pubmed]
PHST- 2015/06/13 06:00 [medline]
AID - 10.1111/ane.12287 [doi]
PST - ppublish
SO  - Acta Neurol Scand. 2015 Jan;131(1):9-16. doi: 10.1111/ane.12287. Epub 2014 Sep