Summary.
NT 201 is a new development of Botulinum Toxin Type A free of complexing proteins. In this double-blind Phase III trial, we compared the efficacy and safety of NT 201 and BOTOX® in patients suffering from blepharospasm. Of 304 enrolled patients, 300 patients received study medication (intent-to-treat population), and 256 patients completed the study as planned (per-protocol population). At baseline, patients received a single injection of NT 201 or BOTOX® (≤35 units per eye). No significant differences were found between NT 201 and BOTOX® for all efficacy and safety variables three weeks after injection. Both the NT 201 and the BOTOX® group showed a decrease in the Jankovic Rating Scale (JRS) sum score signifying an improvement in the symptoms of blepharospasm during this time period. These data show that NT 201* is an effective and safe treatment for patients suffering from blepharospasm.
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References
Allergan Pharmaceuticals (Ireland) Ltd (2004) BOTOX® (Botulinum Toxin Type A). Purified Neurotoxin Complex (Package Insert). July 2004
RL Anderson BC Patel JB Holds DR Jordan (1998) ArticleTitleBlepharospasm: past, present and future. Ophthal Plast Reconstr Surg 14 305–317 Occurrence Handle1:STN:280:DyaK1cvls1Kiuw%3D%3D Occurrence Handle9783280
M Aramideh LJ Bour JH Koelman JD Speelman BW Ongerboer de Visser (1994) ArticleTitleAbnormal eye movements in blepharospasm and involuntary levator palpebrae inhibition. Clinical and pathophysiological considerations. Brain 117 1457–1474 Occurrence Handle7820580
M Aramideh V De Ongerboer JW Brans JH Koelman JD Speelman (1995) ArticleTitlePretarsal application of botulinum toxin for treatment of blepharospasm. J Neurol Neurosurg Psychiatry 59 309–311 Occurrence Handle1:STN:280:ByqH3cvisFQ%3D Occurrence Handle7673963
G Borodic E Johnson M Goodnough E Schantz (1996) ArticleTitleBotulinum toxin therapy immunologic resistance and problems with available materials. Neurology 46 26–29 Occurrence Handle1:STN:280:BymC2czhsFA%3D Occurrence Handle8559392
MF Brin S Fahn C Moskowitz A Friedman HM Shale PE Greene A Blitzer T List D Lange RE Lovelace D McMahon (1987) ArticleTitleLocalized injections of botulinum toxin for the treatment of focal dystonia and hemifacial spasm. Mov Disord 2 237–254 Occurrence Handle10.1002/mds.870020402 Occurrence Handle1:STN:280:BiaD2s%2FlslA%3D Occurrence Handle3504553
CL Burns JA Gammon MC Gemmill (1986) ArticleTitlePtosis associated with botulinum toxin treatment of strabismus and blepharospasm. Ophthalmology 93 1621–1627 Occurrence Handle1:STN:280:BiiC3MnpslU%3D Occurrence Handle3808621
Costa J, Espirito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, Sampaio C (2004) Botulinum toxin type A therapy for blepharospasm. The Cochrane Database of Systematic Reviews Issue 2 (Art No: CD004900pub2; DOI:101002/14651858CD004900pub2 2004)
G Defazio P Livrea R De Salvia G Manobianca V Coviello D Anaclerio V Guerra D Martino F Valluzzi R Liguori G Logroscino (2001) ArticleTitlePrevalence of primary blepharospasm in a community of Puglia region, Southern Italy. Neurology 56 1579–1581 Occurrence Handle1:STN:280:DC%2BD3MzjsVejtQ%3D%3D Occurrence Handle11402121
D Dressler (2004) ArticleTitleClinical presentation and management of antibody-induced failure of botulinum toxin therapy. Mov Disord 19 S92–S100 Occurrence Handle10.1002/mds.20022 Occurrence Handle15027060
InstitutionalAuthorNameEpidemiologic Study of Dystonia in Europe (1999) ArticleTitleSex-related influences on the frequency and age of onset of primary dystonia. Neurology 53 1871–1873
G Galardi D Perani F Grassi S Bressi S Amadio M Antoni GC Comi N Canal F Fazio (1996) ArticleTitleBasal ganglia and thalamo-cortical hypermetabolism in patients with spasmodic torticollis. Acta Neurol Scand 94 172–176 Occurrence Handle1:STN:280:ByiD2Mvns1U%3D Occurrence Handle8899050
R Goertelmeyer S Brinkmann G Comes A Delcker (2002) ArticleTitleThe Blepharospasm Disability Index (BSDI) for the assessment of functional health in focal dystonia. Clin Neurophysiol 113 IssueID[Suppl 1] S77–S78
H Göschel K Wohlfarth J Frevert R Dengler H Bigalke (1997) ArticleTitleBotulinum A toxin therapy: neutralizing and nonneutralizing antibodies – therapeutic consequences. Exp Neurol 147 96–102 Occurrence Handle9294406
F Grandas J Elston N Quinn CD Marsden (1988) ArticleTitleBlepharospasm: a review of 264 patients. J Neurol Neurosurg Psychiatry 51 767–772 Occurrence Handle1:STN:280:BieA3c%2FgvFc%3D Occurrence Handle3404184
P Greene S Fahn B Diamond (1994) ArticleTitleDevelopment of resistance to botulinum toxin type A in patients with torticollis. Mov Disord 9 213–217 Occurrence Handle10.1002/mds.870090216 Occurrence Handle1:STN:280:ByuB2MvptFY%3D Occurrence Handle8196686
H Iwashige Y Nemeto H Takahashi T Maruo (1995) ArticleTitleBotulinum toxin type A purified neurotoxin complex for the treatment of blepharospasm: a dose-response study measuring eyelid force. Jpn J Ophthalmol 39 424–431 Occurrence Handle1:STN:280:BymB2cvpsVc%3D Occurrence Handle8926651
Jankovic J (2002) Dystonia: medical therapy and botulinum toxin. Paper, 4th International dystonia symposium, Atlanta, GA, USA, June 2002 (not specified 119–123)
J Jankovic J Orman (1984) ArticleTitleBlepharospasm: demographic and clinical survey of 250 patients. Ann Ophthalmol 16 371–376 Occurrence Handle1:STN:280:BiuB3c7ktFw%3D Occurrence Handle6144283
J Jankovic J Orman (1987) ArticleTitleBotulinum A toxin for cranial-cervical dystonia: a double-blind placebo-controlled study. Neurology 37 616–623 Occurrence Handle1:STN:280:BiiC2szls1Y%3D Occurrence Handle3561773
J Jankovic KD Vuong J Ahsan (2003) ArticleTitleComparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 60 1186–1188 Occurrence Handle1:STN:280:DC%2BD3s7msFSgtw%3D%3D Occurrence Handle12682332
WH Jost A Kohl S Brinkmann G Comes (2004) ArticleTitleEfficacy and tolerability of a botulinum toxin type A free of complexing proteins (NT 201) compared with commercially available botulinum toxin type A (BOTOX®) in healthy volunteers. J Neural Transm 112 905–913 Occurrence Handle15526142
RW Kristan OG Stasior (1987) ArticleTitleTreatment of blepharospasm with high dose brow injection of botulinum toxin. Ophthal Plast Reconstr Surg 3 25–27 Occurrence Handle1:STN:280:By6C2MbislQ%3D Occurrence Handle3154571
JA Mauriello T Leone S Dhillon B Pakeman R Mostafavi MC Yepez (1996) ArticleTitleTreatment choices of 119 patients with hemifacial spasm over 11 years. Clin Neurol Neurosurg 98 213–216 Occurrence Handle10.1016/0303-8467(96)00025-X Occurrence Handle8884091
K Nakashima M Kusumi Y Inoue K Takahashi (1995) ArticleTitlePrevalence of focal dystonias in the western area of Tottori Prefecture in Japan. Mov Disord 10 440–443 Occurrence Handle10.1002/mds.870100406 Occurrence Handle1:STN:280:BymD38fkslQ%3D Occurrence Handle7565823
NIH (1990) Clinical use of Botulinum Toxin. NIH Consens Statement Online 8(8): 1–20 (November 12, 1990)
JD Rollnik M Matzke K Wohlfarth R Dengler H Bigalke (2000) ArticleTitleLow-dose treatment of cervical dystonia blepharospasm and facial hemispasm with albumin-diluted botulinum toxin type A under EMG guidance. An open label study. Eur Neurol 43 9–12 Occurrence Handle10.1159/000008121 Occurrence Handle1:CAS:528:DC%2BD3cXpt1aquw%3D%3D Occurrence Handle10601802
AB Scott RA Kennedy HA Stubbs (1985) ArticleTitleBotulinum A toxin injection as a treatment for blepharospasm. Arch Ophthalmol 103 347–350 Occurrence Handle1:STN:280:BiqC2cfntFA%3D Occurrence Handle3977705
InstitutionalAuthorNameSubcommittee of the American Academy of Neurology (1994) ArticleTitleTraining guidelines for the use of botulinum toxin for the treatment of neurologic disorders. Report of the Therapeutics and Technology Assessment. Neurology 44 2401–2403
JL Vitek (2002) ArticleTitlePathophysiology of dystonia: a neuronal model. Mov Disord 17 S49–S62 Occurrence Handle11948755
J Wissel J Müller J Dressnandt F Heinen M Naumann H Topka W Poewe (2000) ArticleTitleManagement of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage 20 44–49 Occurrence Handle10.1016/S0885-3924(00)00146-9 Occurrence Handle1:STN:280:DC%2BD3cvlvFSmtg%3D%3D Occurrence Handle10946168
K Wohlfarth C Mueller (2005) ArticleTitleSafety efficacy and duration of effect of a new botulinum neurotoxin type A preparation free of complexing proteins. Mov Disord 20 S11
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*The trade name of NT 201 is Xeomin®
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Roggenkämper, P., Jost, W., Bihari, K. et al. Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm 113, 303–312 (2006). https://doi.org/10.1007/s00702-005-0323-3
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DOI: https://doi.org/10.1007/s00702-005-0323-3