PMID- 22878432
OWN - NLM
STAT- MEDLINE
DCOM- 20130614
LR  - 20220408
IS  - 1432-1459 (Electronic)
IS  - 0340-5354 (Linking)
VI  - 260
IP  - 1
DP  - 2013 Jan
TI  - Sativex long-term use: an open-label trial in patients with spasticity due to 
      multiple sclerosis.
PG  - 285-95
LID - 10.1007/s00415-012-6634-z [doi]
AB  - Sativex is an endocannabinoid system modulator principally containing 
      Delta(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD). During a 6-week randomised 
      controlled trial, Sativex had a clinically relevant effect on spasticity 
      associated with multiple sclerosis (MS). Patients self-titrated oromucosal 
      Sativex to symptom relief or maximum tolerated dose (maximum of 130 mg THC and 
      120 mg CBD daily). The primary objective was to evaluate the safety and 
      tolerability of long-term treatment by recording the incidence and severity of 
      adverse events (AEs). Secondary outcomes were to determine evidence of developing 
      tolerance and to assess the long-term dosing profile of Sativex. A validated 
      11-point Numerical Rating Scale of spasticity severity was used to assess 
      efficacy. A total of 146 patients elected to enter this open-label follow-up 
      safety trial. Mean treatment exposure was 334 days (standard deviation, SD = 209 
      days), and patients administered on average 7.3 (SD = 4.42) actuations per day. 
      Fifty-two (36 %) patients withdrew from the study in the first year, 14 % due to 
      AEs and 9 % due to lack of efficacy. Most AEs were mild/moderate in severity. 
      Common (>10 %) treatment-related AEs were dizziness (24.7 %) and fatigue (12.3 
      %). Serious AEs occurred in five patients (3.4 %), with two psychiatric events 
      reported by one patient. No psychoses, psychiatric AE trends, or withdrawal 
      symptoms occurred following abrupt cessation of treatment. Baseline symptoms 
      including spasticity did not deteriorate but were maintained to study completion 
      in those patients who did not withdraw. No new safety concerns were identified 
      with chronic Sativex treatment, and serious AEs were uncommon. There was no 
      evidence of tolerance developing, and patients who remained in the study reported 
      continued benefit.
FAU - Serpell, Michael G
AU  - Serpell MG
AD  - Pain Clinic, Division of Developmental Medicine, Department of Anaesthetics, 
      Gartnavel General Hospital, University of Glasgow, Glasgow, UK. 
      mgserpell@cheerful.com
FAU - Notcutt, William
AU  - Notcutt W
FAU - Collin, Christine
AU  - Collin C
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120810
PL  - Germany
TA  - J Neurol
JT  - Journal of neurology
JID - 0423161
RN  - 0 (Drug Combinations)
RN  - 0 (Oral Sprays)
RN  - 0 (Plant Extracts)
RN  - 19GBJ60SN5 (Cannabidiol)
RN  - 7J8897W37S (Dronabinol)
RN  - K4H93P747O (nabiximols)
SB  - IM
MH  - Cannabidiol/*therapeutic use
MH  - Dronabinol/therapeutic use
MH  - Drug Combinations
MH  - Electrocardiography
MH  - Female
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Multiple Sclerosis/*complications
MH  - Muscle Spasticity/*drug therapy/*etiology
MH  - Oral Sprays
MH  - Pain Measurement
MH  - Phytotherapy/*methods
MH  - Plant Extracts/*administration & dosage
MH  - Sleep/drug effects
EDAT- 2012/08/11 06:00
MHDA- 2013/06/15 06:00
CRDT- 2012/08/11 06:00
PHST- 2012/03/21 00:00 [received]
PHST- 2012/07/18 00:00 [accepted]
PHST- 2012/07/09 00:00 [revised]
PHST- 2012/08/11 06:00 [entrez]
PHST- 2012/08/11 06:00 [pubmed]
PHST- 2013/06/15 06:00 [medline]
AID - 10.1007/s00415-012-6634-z [doi]
PST - ppublish
SO  - J Neurol. 2013 Jan;260(1):285-95. doi: 10.1007/s00415-012-6634-z. Epub 2012 Aug 
      10.