161
Views
3
CrossRef citations to date
0
Altmetric
Short Communication

Effect of Nabiximols On Goal Attainment Scale Scores in Patients With treatment-resistant Multiple Sclerosis Spasticity

ORCID Icon & ORCID Icon
Pages 143-153 | Received 17 Nov 2020, Accepted 11 Feb 2021, Published online: 01 Mar 2021

References

  • eMC . Sativex oromucosal spray. SmPC, (2020). www.medicines.org.uk/emc/product/602/smpc#gref
  • Arroyo R , VilaC, ClissoldS. Retrospective observational study of the management of multiple sclerosis patients with resistant spasticity in Spain: the ‘5E’ study. Expert Rev. Pharmacoecon. Outcomes Res., 11(2), 205–213 (2011).
  • Arroyo R , MassanaM, VilaC. Correlation between spasticity and quality of life in patients with multiple sclerosis: the CANDLE study. Int. J. Neurosci., 123(12), 850–858 (2013).
  • Oreja-Guevara C , González-SeguraD, VilaC. Spasticity in multiple sclerosis: results of a patient survey. Int. J. Neurosci., 123(6), 400–408 (2013).
  • Svensson J , BorgS, NilssonP. Costs and quality of life in multiple sclerosis patients with spasticity. Acta Neurol. Scand., 129(1), 13–20 (2014).
  • Collin C , DaviesP, MutibokoIK, RatcliffeS. Sativex Spasticity in MS Study Group. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur. J. Neurol., 14(3), 290–296 (2007).
  • Collin C , EhlerE, WaberzinekGet al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol. Res., 32(5), 451–459 (2010).
  • Wade DT , CollinC, StottC, DuncombeP. Meta-analysis of the efficacy and safety of Sativex (nabiximols), on spasticity in people with multiple sclerosis. Mult. Scler., 16(6), 707–714 (2010).
  • Novotna A , MaresJ, RatcliffeSet al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®)), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur. J. Neurol., 18(9), 1122–1131 (2011).
  • Markovà J , EssnerU, AkmazBet al. Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial. Int. J. Neurosci., 129(2), 119–128 (2019).
  • Flachenecker P , HenzeT, ZettlUK. Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice--results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity. Eur. Neurol., 71(5–6), 271–279 (2014).
  • Koehler J , FenebergW, MeierM, PöllmannW. Clinical experience with THC:CBD oromucosal spray in patients with multiple sclerosis-related spasticity. Int. J. Neurosci., 124(9), 652–656 (2014).
  • Etges T , KaroliaK, GrintTet al. An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray. Ther. Clin. Risk Manag., 12, 1667–1675 (2016).
  • Patti F , MessinaS, SolaroCet al. Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. J. Neurol. Neurosurg. Psychiatry, 87(9), 944–951 (2016).
  • Notcutt WG . A questionnaire survey of patients and carers of patients prescribed Sativex as an unlicensed medicine. Prim. Health Care Res. Dev., 14(2), 192–199 (2013).
  • Arroyo R , VilaC, DechantKL. Impact of Sativex(®) on quality of life and activities of daily living in patients with multiple sclerosis spasticity. J. Comp. Eff. Res., 3(4), 435–444 (2014).
  • Kiresuk TJ , ShermanRE. Goal attainment scaling: a general method for evaluating comprehensive community mental health programs. Community Ment. Health J., 4(6), 443–453 (1968).
  • Khan F , PallantJF, Turner-StokesL. Use of goal attainment scaling in inpatient rehabilitation for persons with multiple sclerosis. Arch. Phys. Med. Rehabil., 89(4), 652–659 (2008).
  • Turner-Stokes L , WilliamsH, JohnsonJ. Goal attainment scaling: does it provide added value as a person-centred measure for evaluation of outcome in neurorehabilitation following acquired brain injury?J. Rehabil. Med., 41(7), 528–535 (2009).
  • Ashford S , Turner-StokesL. Goal attainment for spasticity management using botulinum toxin. Physiother. Res. Int., 11(1), 24–34 (2006).
  • Ashford S , Turner-StokesL. Management of shoulder and proximal upper limb spasticity using botulinum toxin and concurrent therapy interventions: a preliminary analysis of goals and outcomes. Disabil. Rehabil., 31(3), 220–226 (2009).
  • Turner-Stokes L , FheodoroffK, JacintoJ, MaisonobeP, ZakineB. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice. BMJ Open, 3(3), e002230 (2013).
  • Turner-Stokes L , FheodoroffK, JacintoJ, MaisonobeP. Results from the Upper Limb International Spasticity Study-II (ULISII): a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ Open, 3(6), e002771 (2013).
  • Turner-Stokes L , AshfordS, JacintoJ, MaisonobeP, BalcaitieneJ, FheodoroffK. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open, 6(6), e011157 (2016).
  • Mahoney FI , BarthelDW. Functional evaluation: the Barthel Index. Md. State Med. J., 14, 61–65 (1965).
  • Heesen C , HaaseR, MelzigSet al. Perceptions on the value of bodily functions in multiple sclerosis. Acta Neurol. Scand., 137(3), 356–362 (2018).
  • Turner-Stokes L . Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin. Rehabil., 23(4), 362–370 (2009).
  • Urach S , GaasterlandC, PoschMet al. Statistical analysis of Goal Attainment Scaling endpoints in randomised trials. Stat. Methods Med. Res., 28(6), 1893–1910 (2019).
  • Gehr S , KaiserT, KreutzR, LudwigWD, PaulF. Suggestions for improving the design of clinical trials in multiple sclerosis-results of a systematic analysis of completed phase III trials. EPMA J., 10(4), 425–436 (2019).
  • Polman CH , ReingoldSC, BanwellBet al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann. Neurol., 69(2), 292–302 (2011).
  • Lublin FD , ReingoldSC, CohenJAet al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology, 83(3), 278–286 (2014).
  • Thompson AJ , BanwellBL, BarkhofFet al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol., 17(2), 162–173 (2018).
  • Farrar JT , TroxelAB, StottC, DuncombeP, JensenMP. 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., 30(5), 974–985 (2008).
  • Hobart JC , RiaziA, LampingDL, FitzpatrickR, ThompsonAJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology, 60(1), 31–36 (2003).
  • Guy W . National Institute of Mental Health (U.S.), Psychopharmacology Research Branch, Early Clinical Drug Evaluation Program. ECDEU Assessment Manual for Psychopharmacology.U.S. Dept. of. Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch. Division of Extramural Research Programs, MD, USA (1976).
  • Veauthier C , HasselmannH, GoldSM, PaulF. The Berlin Treatment Algorithm: recommendations for tailored innovative therapeutic strategies for multiple sclerosis-related fatigue. EPMA J., 7(1), 25 (2016).
  • Gaede G , TiedeM, LorenzIet al. Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue. Neurol. Neuroimmunol. Neuroinflamm., 5(1), e423 (2017).
  • von Bismarck O , DankowskiT, AmbrosiusBet al. Treatment choices and neuropsychological symptoms of a large cohort of early MS. Neurol. Neuroimmunol. Neuroinflamm., 5(3), e446 (2018).
  • Mehta L , McNeillM, HobartJet al. Identifying an important change estimate for the Multiple Sclerosis Walking Scale-12 (MSWS-12v1) for interpreting clinical trial results. Mult. Scler. J. Exp. Transl. Clin., 1, 2055217315596993 (2015).
  • Motl RW , PutzkiN, PiluttiLA, CadavidD. Longitudinal changes in self-reported walking ability in multiple sclerosis. PLoS ONE, 10(5), e0125002 (2015).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.