Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in clinical practice - results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity

European Neurology

Volumn 71, Issue 5-6, 2014, Pages 271-279

  Flachenecker, Peter ^a   Henze, Thomas ^b   Zettl, Uwe K ^c  

^a Neurological Rehabilitation Center Quellenhof   (Germany)

^b Passauer Wolf Rehabilitation Center Nittenau   (Germany)

^c UNIVERSITY OF ROSTOCK   (Germany)

Author keywords

Cannabinoids; Effectiveness; Multiple sclerosis; Nabiximols; Spasticity; Tolerability

Indexed keywords

BACLOFEN; GABAPENTIN; NABIXIMOLS; SPASMOLYTIC AGENT; TIZANIDINE; TOLPERISONE; CANNABIDIOL; DRONABINOL; DRUG COMBINATION; MUSCLE RELAXANT AGENT; PLANT EXTRACT; TETRAHYDROCANNABINOL-CANNABIDIOL COMBINATION;

ADD ON THERAPY; ADULT; AEROSOL; AGED; ARTICLE; DISEASE SEVERITY; DIZZINESS; DROWSINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; GAIT DISORDER; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; MULTIPLE SCLEROSIS SPASTICITY; MUSCLE SPASM; NAUSEA; OBSERVATIONAL STUDY; PATIENT SATISFACTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; SCORING SYSTEM; SLEEP DISORDER; SPASTICITY; TREATMENT OUTCOME; URINARY TRACT INFECTION; WEAKNESS; XEROSTOMIA; CLINICAL TRIAL; DRUG COMBINATION; DRUG EFFECTS; GERMANY; MIDDLE AGED; MUSCLE SPASTICITY; PATHOPHYSIOLOGY; QUESTIONNAIRE; SEVERITY OF ILLNESS INDEX; SLEEP; YOUNG ADULT; ANXIETY; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; COMORBIDITY; DEPRESSION; DISEASE EXACERBATION; DRUG SURVEILLANCE PROGRAM; EXPANDED DISABILITY STATUS SCALE; MEDICAL DOCUMENTATION; MEDICAL SPECIALIST; NUMERICAL RATING SCALE; RATING SCALE; TREATMENT RESPONSE; WALKING DIFFICULTY;

ADULT; AGED; CANNABIDIOL; DRONABINOL; DRUG COMBINATIONS; FEMALE; FOLLOW-UP STUDIES; GERMANY; HUMANS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; MUSCLE SPASTICITY; NEUROMUSCULAR AGENTS; PLANT EXTRACTS; PROSPECTIVE STUDIES; QUESTIONNAIRES; SEVERITY OF ILLNESS INDEX; SLEEP; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84901684390     PISSN: 00143022     EISSN: 14219913     Source Type: Journal    
DOI: 10.1159/000357427     Document Type: Article

References (24)

1. Kabus C, Hecht M, Japp G, Jost WH, Pohlau D, Stuckrad-Barre S, Winterholler M: Botulinum toxin in patients with multiple sclerosis. J Neurol 2006; 253(suppl 1):I/26-I/28
2. Beard S, Hunn A, Wight J: Treatments for spasticity and pain in multiple sclerosis: A systematic review. Health Technol Assess 2003;7:iii, ix-x, 1-111
3. Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL: Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004; 10: 589-595. (Pubitemid 39207235
4. Deutsche Gesellschaft fur Neurologie. Leitlinien fur Diagnostik und Therapie in der Neurologie-Diagnose und Therapie der Multiplen Sklerose; Version January 2012. http://www.dgn.org/component/content/ article/45-leitlinien-der- dgn-2012/2333-II-31-2012-diagnose-und-Therapie-dermultiplen-sklerose.html?q= multiple+ sklerose (accessed January 23, 2013) .
5. Novotna A, Mares J, Ratcliffe S, Novakoval I, Vachova M, Zapletalova O, Gasperini C, Pozzilli C, Cefaro L, Comi G, Rossi P, Ambler Z, Stelmasiak Z, Erdmann A, Montalban X, Klimek A, Davies P; Sativex Spasticity Study Group: A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols (Sativex ®) , as addon therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol 2011; 18: 1122-1131
6. Wade DT, Collin C, Scott C, Duncombe P: Meta-Analysis of the efficacy and safety of Sativex (nabiximols), on spasticity in people with multiple sclerosis. Mult Scler 2010; 16: 707-714
7. Nottcut W, Langford R, Davies P, Ratcliffe S, Potts R: A placebo-controlled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-Term Sativex ® (nabiximols). Mult Scler 2012; 18: 219-228
8. Serpell MG, Notcutt W, Collin C: Sativex long-Term use: An-open label trial in patients with spasticity due to multiple sclerosis. J Neurol 2013; 260: 285-295
9. Summary of Product Characteristics (SmPC) Sativex Oromucosal Spray. Date of Revision: July 28, 2011
10. EuroQol Group: EuroQol-A new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208
11. Szende A, Oppe M, Delvin N: EQ-5D Value Sets: Inventory, Comparative Review and User Guide. EuroQol Group Monographs, vol 2. Berlin, Springer, 2007
12. Vickrey G, Hays RD, Harooni F, Myers LW, Ellison GW: A health-related quality of life measure for multiple sclerosis. Qual Life Res 1995; 4: 187-202
13. Vickrey BG: Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument (Scoring Manual). Los Angeles, University of California, 1995
14. Farrar JT, Troxel AB, Stott C, Duncombe P, Jensen MP: Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: A post hoc analysis of a randomized, double-blind, placebocontrolled trial. Clin Ther 2008; 30: 974-985. (Pubitemid 351799873
15. Bohannon RW, Smith MB: Interrater reliability of a modified Ashworth Scale of muscle spasticity. Phys Ther 1987; 67: 206-207. (Pubitemid 17026064
16. Mahoney FI, Barthel D: Functional evaluation: The Barthel Index. Md State Med J 1965; 14: 56-61
17. Collin C, Wade DT, Davies S, Horne V: The Barthel ADL Index: A reliability study. Int Disabil Stud 1988; 10: 61-63
18. Kurtzke JF: Rating neurologic impairment in multiple sclerosis: An Expanded Disability Status Scale (EDSS). Neurology 1983; 33: 1444-1452
19. Kurtzke JF: Natural history and clinical outcome measures for multiple sclerosis studies. Why at the present time does EDSS scale remain a preferred outcome measure to evaluate disease evolution?. Neurol Sci 2000; 21: 339-341
20. Collin C, Davies P, Mutiboko IK, Ratcliffe S: Randomized controlled trial of cannabisbased medicine in spasticity caused by multiple sclerosis. Eur J Neurol 2007; 14: 290-296. (Pubitemid 46384865
21. Collin C, Ehler E, Waberzinek G, Alsindi Z, Davies P, Powell K, Notcutt W, O'Leary C, Ratcliffe S, Novakova I, Zapletalova O, Pikova J, Ambler Z: A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiples sclerosis. Neurol Res 2010; 32: 451-459
22. Fleuren JF, Voerman GE, Erren-Wolters CV, Snoek GJ, Rietman JS, Hermens HJ, Nene AV: Stop using the Ashworth Scale for the assessment of spasticity. J Neurol Neurosurg Psychiatry 2010; 81: 46-52
23. Sunnerhagen KS: Stop using the Ashworth Scale for the assessment of spasticity. J Neurol Neurosurg Psychiatry 2010; 81: 2 .
24. Flachenecker P, Zettl U, Essner U, Henze T: Drug treatment of spasticity in multiple sclerosis-A cross-sectional survey in Germany. Lyon, ECTRIMS, 2012, poster 1029