Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm

Journal of Neural Transmission

Volumn 113, Issue 3, 2006, Pages 303-312

  Roggenkamper P ^a   Jost, W H ^b   Bihari, K ^c   Comes, G ^d   Grafe, S ^d  

^a UNIVERSITY OF BONN   (Germany)

^b DEUTSCHE KLINIK FÜR DIAGNOSTIK   (Germany)

^c Orszagos Idegsebeszeti Tudomanyos Intezet Budapest   (Hungary)

^d MERZ PHARMACEUTICALS GMBH   (Germany)

Author keywords

Blepharospasm; Botulinum toxin type A

Indexed keywords

BOTULINUM TOXIN A; NT 201; PROTEIN DERIVATIVE; UNCLASSIFIED DRUG;

ABNORMAL VISION; ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BLEPHAROSPASM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FACE EDEMA; FEMALE; HEADACHE; HEART PALPITATION; HUMAN; MAJOR CLINICAL STUDY; MALE; PARESTHESIA; PHASE 3 CLINICAL TRIAL; PHOTOPHOBIA; PRIORITY JOURNAL; PTOSIS; RASH; TIME SERIES ANALYSIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; XEROPHTHALMIA;

ADULT; AGED; AGED, 80 AND OVER; BLEPHAROSPASM; BOTULINUM TOXIN TYPE A; DOUBLE-BLIND METHOD; EYELIDS; FEMALE; HEMAGGLUTININS; HUMANS; MALE; MIDDLE AGED; MUSCLE, SKELETAL; NEUROMUSCULAR AGENTS; TREATMENT OUTCOME;

EID: 32044437587     PISSN: 03009564     EISSN: 14351463     Source Type: Journal    
DOI: 10.1007/s00702-005-0323-3     Document Type: Article

References (32)

1. Allergan Pharmaceuticals (Ireland) Ltd (2004) BOTOX® (Botulinum Toxin Type A). Purified Neurotoxin Complex (Package Insert). July 2004
2. RL Anderson BC Patel JB Holds DR Jordan 1998 Blepharospasm: past, present and future. Ophthal Plast Reconstr Surg 14 305 317
3. M Aramideh LJ Bour JH Koelman JD Speelman BW Ongerboer de Visser 1994 Abnormal eye movements in blepharospasm and involuntary levator palpebrae inhibition. Clinical and pathophysiological considerations. Brain 117 1457 1474
4. M Aramideh V De Ongerboer JW Brans JH Koelman JD Speelman 1995 Pretarsal application of botulinum toxin for treatment of blepharospasm. J Neurol Neurosurg Psychiatry 59 309 311
5. G Borodic E Johnson M Goodnough E Schantz 1996 Botulinum toxin therapy immunologic resistance and problems with available materials. Neurology 46 26 29
6. MF Brin S Fahn C Moskowitz A Friedman HM Shale PE Greene A Blitzer T List D Lange RE Lovelace D [tmp] McMahon 1987 Localized injections of botulinum toxin for the treatment of focal dystonia and hemifacial spasm. Mov Disord 2 237 254
7. CL Burns JA Gammon MC Gemmill 1986 Ptosis associated with botulinum toxin treatment of strabismus and blepharospasm. Ophthalmology 93 1621 1627
8. 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)
9. G Defazio P Livrea R De Salvia G Manobianca V Coviello D Anaclerio V Guerra D Martino F Valluzzi R Liguori G Logroscino 2001 Prevalence of primary blepharospasm in a community of Puglia region, Southern Italy. Neurology 56 1579 1581
10. D Dressler 2004 Clinical presentation and management of antibody-induced failure of botulinum toxin therapy. Mov Disord 19 S92 S100
11. Epidemiologic Study of Dystonia in Europe 1999 Sex-related influences on the frequency and age of onset of primary dystonia. Neurology 53 1871 1873
12. G Galardi D Perani F Grassi S Bressi S Amadio M Antoni GC Comi N Canal F Fazio 1996 Basal ganglia and thalamo-cortical hypermetabolism in patients with spasmodic torticollis. Acta Neurol Scand 94 172 176
13. R Goertelmeyer S Brinkmann G Comes A Delcker 2002 The Blepharospasm Disability Index (BSDI) for the assessment of functional health in focal dystonia. Clin Neurophysiol 113 [Suppl 1] S77 S78
14. H Göschel K Wohlfarth J Frevert R Dengler H Bigalke 1997 Botulinum A toxin therapy: neutralizing and nonneutralizing antibodies - therapeutic consequences. Exp Neurol 147 96 102
15. F Grandas J Elston N Quinn CD Marsden 1988 Blepharospasm: a review of 264 patients. J Neurol Neurosurg Psychiatry 51 767 772
16. P Greene S Fahn B Diamond 1994 Development of resistance to botulinum toxin type A in patients with torticollis. Mov Disord 9 213 217
17. H Iwashige Y Nemeto H Takahashi T Maruo 1995 Botulinum toxin type A purified neurotoxin complex for the treatment of blepharospasm: a dose-response study measuring eyelid force. Jpn J Ophthalmol 39 424 431
18. Jankovic J (2002) Dystonia: medical therapy and botulinum toxin. Paper, 4th International dystonia symposium, Atlanta, GA, USA, June 2002 (not specified 119-123)
19. J Jankovic J Orman 1984 Blepharospasm: demographic and clinical survey of 250 patients. Ann Ophthalmol 16 371 376
20. J Jankovic J Orman 1987 Botulinum A toxin for cranial-cervical dystonia: a double-blind placebo-controlled study. Neurology 37 616 623
21. J Jankovic KD Vuong J Ahsan 2003 Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 60 1186 1188
22. ®) in healthy volunteers. J Neural Transm 112 905 913
23. RW Kristan OG Stasior 1987 Treatment of blepharospasm with high dose brow injection of botulinum toxin. Ophthal Plast Reconstr Surg 3 25 27
24. JA Mauriello T Leone S Dhillon B Pakeman R Mostafavi MC Yepez 1996 Treatment choices of 119 patients with hemifacial spasm over 11 years. Clin Neurol Neurosurg 98 213 216
25. K Nakashima M Kusumi Y Inoue K Takahashi 1995 Prevalence of focal dystonias in the western area of Tottori Prefecture in Japan. Mov Disord 10 440 443
26. NIH (1990) Clinical use of Botulinum Toxin. NIH Consens Statement Online 8(8): 1-20 (November 12, 1990)
27. JD Rollnik M Matzke K Wohlfarth R Dengler H Bigalke 2000 Low-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
28. AB Scott RA Kennedy HA Stubbs 1985 Botulinum A toxin injection as a treatment for blepharospasm. Arch Ophthalmol 103 347 350
29. Subcommittee of the American Academy of Neurology 1994 Training guidelines for the use of botulinum toxin for the treatment of neurologic disorders. Report of the Therapeutics and Technology Assessment. Neurology 44 2401 2403
30. JL Vitek 2002 Pathophysiology of dystonia: a neuronal model. Mov Disord 17 S49 S62
31. J Wissel J Müller J Dressnandt F Heinen M Naumann H Topka W Poewe 2000 Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage 20 44 49
32. K Wohlfarth C Mueller 2005 Safety efficacy and duration of effect of a new botulinum neurotoxin type A preparation free of complexing proteins. Mov Disord 20 S11