A double blind, randomised, parallel group study to investigate the dose equivalence of Dysport® and Botox® in the treatment of cervical dystonia

Journal of Neurology Neurosurgery and Psychiatry

Volumn 64, Issue 1, 1998, Pages 6-12

  Odergren, T ^a   Hjaltason, H ^a   Kaakkola, S ^b   Solders, G ^a   Hanko, J ^c   Fehling, C ^c   Marttila, R J ^d   Lundh, H ^e   Gedin, S ^f   Westergren, I ^f   Richardson, A ^g   Dott, C ^g   Cohen, H ^g  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b UNIVERSITY OF HELSINKI   (Finland)

^c Helsingborg General Hospital   (Sweden)

^d UNIVERSITY OF TURKU   (Finland)

^e University of Turku ^*  (Sweden)

^f LUND UNIVERSITY   (Sweden)

^g Speywood Pharmaceuticals   (United Kingdom)

Author keywords

Bioequivalence; Botulinum toxin; Cervical dystonia

Indexed keywords

BOTULINUM TOXIN A;

ADULT; AGED; ARTICLE; CERVICAL SPINAL CORD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPHAGIA; DYSPHONIA; DYSTONIA; EPISTAXIS; FATIGUE; FEMALE; HEADACHE; HUMAN; INTRAMUSCULAR DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MIGRAINE; MUSCLE WEAKNESS; NECK PAIN; PHARYNGITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; XEROSTOMIA;

EID: 6844239534     PISSN: 00223050     EISSN: None     Source Type: Journal    
DOI: 10.1136/jnnp.64.1.6     Document Type: Article

References (17)

1. American Academy of Neurology Therapeutics and Technology Assessment Subcommittee. Assessment: the clinical usefulness of botulinum toxin-A in treating neurologic disorders. Neurology 1990;40:1332-6.
2. Nutt JG, Muenter MD, Aronson A, Kurland LT, Melton LJ, Epidemiology of focal dystonia in Rochester, Minnesota. Mov Disord 1988;3:188-94.
3. Coffield JA, Considine RV, Simpson LL. The site and mechanism of action of botulinum neurotoxin. In: Jankovic J, Hallett AI, eds. Therapy with botulinum toxin. New York: Marcel Dekker, 1994:3-15.
4. Odergren T, Tollbäck A, Borg J. Electromyographic single motor unit potentials after repeated botulinum toxin treatments in cervical dystonia. Electroencephalogr Clin Neurophysiol 1994;93:325-9.
5. Hambleton P, Pickett AM. Potency equivalence of botulinum toxin preparations. J R Soc Med 1994;87:719.
6. Marion MH, Sheehy AI, Sangla S, Soulayrol S. Dose standardisation of botulinum toxin. J Neurology Neurosurg Psychiatry 1995;59:102-3.
7. Whurr R, Brookes G, Barnes C. Comparison of dosage effects between the American and the British botulinum toxin A product - in the treatment of spasmodic dysphonia. Mov Disord 1995;10:56.
8. Tsui JKC, Eisen A, Stoessl AJ, Calne S, Calne DB. Doubleblind study of botulinum toxin in spasmodic torticollis. Lancet 1986;ii:245-7.
9. Sampaio C, Ferreira JJ, Simoes F, Rosas MJ, Magalhaes M, Bastos-Lima A, Castro-Caldas A. Dysbot: a single blind, randomised clinical trial to compare two different formulations of botulinum toxin type A. Mov Disord 1995;10:57.
10. Durif F. Clinical bioequivalence of the current commercial preparations of botulinum toxin. European Journal of Neurology 1995;2:17-8.
11. Poewe W, Deaschl G, Nebe A, et al. What is the optimal dose of botulinum toxin A in the treatment of cervical dystonia? Results of a double blind, placebo controlled, dose ranging study using Dysport®. J Neurol Neurosurg Psychiatry 1997; 64:13-17.
12. Consky ES, Lang AE. Clinical assessments of patients with cervical dystonia. In: Jankovic J, Hallett M, eds. Therapy with botulinum toxin. New York: Marcel Dekker, 1994:211-37.
13. Odergren T, Tollbäck A, Borg J. Efficacy of botulinum toxin for cervical dystonia. A comparison of methods for evaluation. Scand J Rehabil Med 1994;26:191-5.
14. Tarsy D. Comparison of clinical rating scales in the treatment of cervical dystonia with botulinum toxin. Mov Disord 1997;12:100-2.
15. Girlanda P, Vita G, Nicolosi C, Milone S, Messina C. Botulinum toxin therapy: distant effects on neuromuscular transmission and autonomic nervous system. J Neurol Neurosurg Psychiatry 1992;55:844-5.
16. Claus D, Druschky A, Erbguth F. Botulinum toxin: influence on respiratory heart rate variation. Mov Disord 1995;10:574-9.
17. Olney RK, Aminoff MJ, Gelb DJ, Lowenstein DH. Neuromuscular effects distant from the site of botulinum neurotoxin injection. Neurology 1988;38:1780-3.