MALVERN, Pa., June 15, 2007 /PRNewswire/ -- Solstice Neurosciences, Inc. today reported important results from a multicenter, forced dose escalation study of Botulinum Toxin Type B Injectable Solution (Myobloc(R)) recently presented at the 11th International Congress of The Movement Disorders Society in Istanbul, Turkey.
This was the first multicenter study to confirm patient safety and efficacy of escalating treatment doses of 10,000 Units, 12,500 Units, and 15,000 Units of Botulinum Toxin Type B in patients with cervical dystonia (CD).
The study results were presented by Eric J. Pappert, MD, who is assistant professor of neurology and director of the Parkinson's Disease and Movement Disorders Program at the University of Texas Health Science Center in San Antonio, Texas. Dr. Pappert also serves as Vice President, Medical & Scientific Affairs of Solstice Neurosciences.
"The recommended initial dose of Type B Toxin for patients with a prior history of tolerating botulinum toxin injections is 2,500 to 5,000 Units, with subsequent dosing to be optimized according to individual patient response. Pivotal clinical trials have used doses of 5,000 and 10,000 Units," said Dr. Pappert. "So, these data provide important insights for understanding how patients respond to higher doses. The results will also help guide the design of future studies."
Highlights from the open-label study included the following: -- 145 Subjects (95% Caucasian, 65% Female, Mean Age=53.1 years) -- Previous experience with neurotoxins -- Resistant to Type A (n=32; 22%) -- Responsive to Type A (n=113; 78%) -- Treatment: 3 escalating doses (10,000 Units, 12,500 Units, 15,000 Units) -- Measurement intervals: baseline, 2 weeks, every 4 weeks -- Effectiveness measurements: -- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score (Torticollis Severity, Disability, Pain) --
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