The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that treatment will decrease symptom severity and will not have any significant side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
100U vials, doses ranged from 50U-200U, single injection.
Single injection.
Mentor Worldwide, LLC
Santa Barbara, California, United States
Absence of significant drug related adverse effects
Time frame: Post-injection
Decrease in symptom severity (TWSTRS)
Time frame: 30 days post-injection
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