http://link.springer.de/link/service/journals/00415/bibs/1248012/12481073.htm
Journal of Neurology
Abstract
Results from a dose-ranging study
in a selected group of de novo patients with rotational cervical dystonia
(CD) suggest that 500 units of Dysport (Clostridium botulinum toxin type
A haemaglutinin complex) is the optimal starting dose. The present study
aimed to confirm the efficacy and safety profile of this dose in a population
of CD patients more representative of those seen in a typical dystonia
clinic.
A total of 68 patients with moderate
to severe CD (Tsui score \geq 9) were randomly assigned to receive placebo
or Dysport 500 units. Treatment was administered according to the clinical
pattern of head deviation, using a standardised injection protocol. A total
of 21 patients (11 Dysport, 10 placebo) had not previously received botulinum
toxin type A (BtxA) injections, and 47 patients (24 Dysport, 23 placebo)
had received BtxA more than 12 weeks previously. Assessments were performed
at baseline and weeks 4, 8 and 16. Patients defined as non-responders at
week 4 were re-treated in an open phase with 500 units of Dysport at week
6, and were followed up at week 10.
Significant between-group differences
in Tsui scores were present at weeks 4 (p=0.001) and 8 (p=0.002). Similarly,
there were significant between-group differences (p < 0.001) in patient
and investigator assessments of response in favour of Dysport at weeks
4 and 8. Also, more Dysport (49 %) than placebo (33 %) patients were pain-free
at week 4 (p=0.02). Overall, 30/35 (86 %) Dysport patients and 14/33 (42
%) placebo patients were classified as responders at week 4. Adverse events
were reported by 15/35 Dysport patients and 9/33 placebo patients. Open
phase treatment produced improvements in Tsui (p < 0.001) and pain scores
(p=0.011), and 23/24 patients were classified as responders.
Although individual dose titration
and muscle selection is desirable, this study demonstrated that a dose
of 500 units of Dysport injected into clinically identified neck muscles
without electromyographic guidance is safe and effective in the treatment
of patients with the major clinical types of cervical dystonia.
© Steinkopff Verlag 2001
Volume 248 Issue 12 (2001) pp 1073-1078
J. Wissel (1), P. Kanovsky (2),
E. Ruzicka (3), M. Bares (2), H. Hortova (2), H. Streitova (2), R. Jech
(3), J. Roth (3), C. Brenneis (1), J. Müller (1), P. Schnider (4),
E. Auff (4), A. Richardson (5), W. Poewe (1)
(1) Universitätsklinik für
Neurologie, Anichstr. 35, 6020 Innsbruck, Austria, Tel.: +43-5 12/5 04-38
50, Fax: +43-5 12/5 04-38 52, E-Mail: werner.poewe@uibk.ac.at
(2) Department of Neurology, Masaryk
University, St. Anne's Hospital, Brno,Czech Republic
(3) Department of Neurology, Charles
University, Prague, Czech Republic
(4) Universitätsklinik für
Neurologie, Vienna, Austria
(5) Ipsen Limited, Maidenhead, UK