Long-term effectiveness and safety of nabiximols (tetrahydrocannabinol/ cannabidiol oromucosal spray) in clinical practice

European Neurology

Volumn 72, Issue 1-2, 2014, Pages 95-102

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

^a Neurologisches Reha Zentrum Quellenhof Bad Wildbad   (Germany)

^b Passauer Wolf Rehabilitation Center Nittenau   (Germany)

^c UNIVERSITY OF ROSTOCK   (Germany)

Author keywords

Cannabinoids; Effectiveness; Long term treatment; Multiple sclerosis; Nabiximols; Spasticity; Tolerability

Indexed keywords

NABIXIMOLS; ANALGESIC AGENT; CANNABIDIOL; DRONABINOL; DRUG COMBINATION; ORAL SPRAY;

ACNE; ADULT; ARTICLE; BRADYPHRENIA; CLINICAL PRACTICE; COLOR BLINDNESS; DEPERSONALIZATION; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GINGIVA PAIN; HEADACHE; HOT FLUSH; HUMAN; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MENTAL DISEASE; MOUTH DISCOMFORT; MOUTH EDEMA; MULTICENTER STUDY; MULTIPLE SCLEROSIS; NAUSEA; NIGHTMARE; ORAL SPRAY; PATIENT SATISFACTION; PERSECUTORY DELUSION; PRIORITY JOURNAL; PSORIASIS; QUALITY OF LIFE; RATING SCALE; SIDE EFFECT; SPASTICITY; STOMATITIS; TREATMENT OUTCOME; XEROSTOMIA; AGED; CLINICAL TRIAL; DRUG COMBINATION; FOLLOW UP; GERMANY; MIDDLE AGED; MUSCLE SPASTICITY; PATHOPHYSIOLOGY; PROSPECTIVE STUDY; QUESTIONNAIRE; SEVERITY OF ILLNESS INDEX; TIME; ANXIETY DISORDER; DISEASE SEVERITY; FRACTURE; MEDICAL DOCUMENTATION; NUMERICAL RATING SCALE; OBSERVATIONAL STUDY;

ADULT; AGED; ANALGESICS; CANNABIDIOL; DRONABINOL; DRUG COMBINATIONS; FEMALE; FOLLOW-UP STUDIES; GERMANY; HUMANS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; MUSCLE SPASTICITY; ORAL SPRAYS; PATIENT SATISFACTION; PROSPECTIVE STUDIES; QUALITY OF LIFE; QUESTIONNAIRES; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84902301875     PISSN: 00143022     EISSN: 14219913     Source Type: Journal    
DOI: 10.1159/000360285     Document Type: Article

References (22)

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.
4. Summary of Product Characteristics (SmPC) Sativex Oromucosal Spray. Date of revision: July 28, 2011.
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. Flachenecker P: A new multiple sclerosis spasticity treatment option: effect in everyday clinical practice and cost-effectiveness in Germany. Expert Rev Neurother 2013; 13(suppl 1):15-19.
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 Values Sets: Inventory, Comparative Review and User Guide. EuroQol Group Monographs. Berlin, Springer, 2007, vol 2.
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, placebo-controlled trial. Clin Ther 2008; 30: 974-985.
15. Bohannon RW, Smith MB: Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987; 67: 206-207.
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. Flachenecker P, Henze H, Zettl UK: Nabiximols (THC/CBD oromucosal spray, Sativex® ) in clinical practice -results of a multicentre, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity. Eur Neurol 2014; 71: 271-279.
21. 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.
22. 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 multiple sclerosis. Neurol Res 2010; 32: 451-459.