BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).
Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open-label, dose-escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose-limiting toxicity in this patient population. Mild-to-moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type-B treatment were reported. Low-dosing-session (100-899 units) and high-dosing-session (900-1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale-Severity Scale (TWSTRS-Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS-Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low-dose and high-dose groups, respectively. EFfectiveness was noted for the high-dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.
Truong
D D
DD
Parkinson and Movement Disorders Program, Irvine, California, USA.
Cullis
P A
PA
O'Brien
C F
CF
Koller
M
M
Villegas
T P
TP
Wallace
J D
JD
D000328:Adult; D000368:Aged; D018726:Anti-Dyskinesia Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D001905:Botulinum Toxins / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004351:Drug Resistance; D004421:Dystonia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D011446:Prospective Studies; D012720:Severity of Illness Index; D014103:Torticollis / Q000188:drug therapy*; D016896:Treatment Outcome
D018726:Anti-Dyskinesia Agents; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A