An open-label, sequential dose-escalation, safety, and tolerability study of rimabotulinumtoxinb in subjects with cervical dystonia

International Journal of Neuroscience

Volumn 120, Issue 11, 2010, Pages 703-710

  Chinnapongse, Robert ^a   Pappert, Eric J ^a   Evatt, Marian ^b   Freeman, Alan ^b   Birmingham, William ^a  

^a Solstice Neurosciences   (United States)

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Botulinum toxin; Cervical dystonia; Myobloc; NeuroBloc; RimabotulinumtoxinB; Type B

Indexed keywords

BOTULINUM TOXIN B;

ADULT; ARTICLE; ASTHENIA; CELLULITIS; CERVICAL DYSTONIA; CHOLELITHIASIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSIVE PSYCHOSIS; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPHAGIA; FEMALE; GASTROENTERITIS; GASTROINTESTINAL CARCINOMA; HUMAN; INJECTION SITE PAIN; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE WEAKNESS; NECK PAIN; NECK WEAKNESS; NEPHROLITHIASIS; NONHODGKIN LYMPHOMA; PEPTIC ULCER; PHYSICAL DISABILITY; RATING SCALE; SARCOIDOSIS; VARICOSIS; VISUAL ANALOG SCALE; VITAL SIGN; XEROSTOMIA;

ANTI-DYSKINESIA AGENTS; BOTULINUM TOXINS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MIDDLE AGED; PAIN; PAIN MEASUREMENT; TORTICOLLIS; TREATMENT OUTCOME;

EID: 77958002491     PISSN: 00207454     EISSN: 15635279     Source Type: Journal    
DOI: 10.3109/00207454.2010.515047     Document Type: Article

References (21)

1. Brashear, A., Lew, M. F., Dykstra, D. D., Comella, C. L., Factor, S. A., Rodnitzky, R. L., et al. (1999). Safety and effcacy of Neu-roBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology, 53(7), 1439-1446.
2. Brin, M. F., Lew, M. F., Adler, C. H., Comella, C. L., Factor, S. A., Jankovic, J., et al. (1999). Safety and effcacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology, 53(7), 1431-1438.
3. Camfeld, L., Ben-Shlomo, Y., & Warner, T. (2002). Epidemiological study of dystonia in Europe Collective Group. Movement Disorders, 17(4), 838-841.
4. Chan, J., Brin, M., & Fahn, S. (1991). Idiopathic cervical dystonia: Clinical characteristics. Movement Disorders, 6, 119-126.
5. Comella, C. L., Jankovic, J., Shannon, K. M., Tsui, J., Swenson, M., Leurgans, S., et al. (2005). Comparison of botulinum toxin serotypes A and B for the treatment of cervical dystonia. Neurology, 65(1), 1423-1429.
6. Comella, C. L., Stebbins, G. T., Goetz, C. G., Chmura, T. A., Bressman, S. B., & Lang, A. E. (1997). Teaching tape for the motor section of the Toronto Western Spasmodic Torticollis Scale. Movement Disorders, 12(4), 570-575.
7. Comella, C. L., Tanner, C. M., DeFloor-Hill, L., & Smith, C. (1992). Dysphagia after botulinum toxin injections for spasmodic torticollis: Clinical and radiologic fndings. Neurology, 42,1307-1310.
8. Consky, E. S., & Lang, A. E. (1994). Clinical assessments of patients with cervical dystonia. In J. Jankovic and M. Hallett (eds.), Therapy with Botulinum Toxin. New York, NY: Marcel Dekker, Inc., 211-237.
9. Costa, J., Esṕ?rito-Santo, C., Borges, A., Ferreira, J. J., Coelho, M., Moore, P., et al. (2004). BoNT-B for cervical dystonia. Cochrane Database of Systematic Reviews, Issue 4. Art. No. CD004315. DOI: 10.1002/14651858.CD004315.pub2.
10. Factor, S. A. (2002). Practical Considerations for the Clinical Use of Bo-tulinum Toxin Type B: A Self-Study Continuing Medical Education Activity. New York, NY: WE MOVE.
11. Factor, S. A., Molho, E. S., Evans, S., & Feustel, P. J. (2005). Effcacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia. Movement Disorders, 20(9), 1152-1160.
12. Jahanshahi, M., & Marsden, C. D. (1988). Depression in torticollis: A controlled study. Psychological Medicine, 18(4), 925-933.
13. Jahanshahi, M., & Marsden, C. D. (1990a). Body concept, disability, and depression in patients with spasmodic torticollis. Behavioural Neurology, 3, 117-131.
14. Jahanshahi, M., & Marsden, C. D. (1990b). A longitudinal follow-up study of depression, disability, and body concept in torticollis. Behavioural Neurology, 3, 233-246.
15. Jankovic, J., Leder, S., Warner, I., & Schwartz, K. (1991). Cervical dystonia: Clinical fndings and associated movement disorders. Neurology, 41, 1088-1091.
16. Lew, M. F. (2002). Botulinum toxin type B: An effective treatment for alleviating pain associated with cervical dystonia. Journal of Back and Musculoskeletal Rehabilitation, 16, 3-9.
17. Lew, M. F., Adornato, B. T., Duane, D. D., Dykstra, D. D., Factor, S. A., Massey, J. M., et al. (1997). Botulinum toxin type B: A double-blind, placebo-controlled, safety and effcacy study in cervical dystonia. Neurology, 49(3), 701-707.
18. Lew, M. F., & Factor, S. A. (2006). A 4 year observational study of repeated dosing with botulinum toxin type B in patients with cervical dystonia [Abstract P05.127]. Neurology, 66(Suppl. 2), A290-A291.
19. Nutt, J. G., Muenter, M. D., Aronson, A., Kurland, L. T., & Melton, L. J., 3rd. (1988). Epidemiology of focal and generalized dystonia in Rochester, Minnesota. Movement Disorders, 3(3), 188-194.
20. Pappert, E. J., & Germanson, T. (2008). Botulinum toxin type B vs. type A in toxin-nä?ve patients with cervical dystonia: Randomized, double-blind, non-inferiority trial. Movement Disorders, 23(4), 510-517.
21. Van Zandijcke, M. (1995). Cervical dystonia (spasmodic torticollis). Some aspects of the natural history. Acta Neurologica Belgica, 95(4), 210-215.