Myobloc® Studied in Type A Responsive….

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Myobloc® Studied in Type A Responsive and Resistant Patients

For the Efficacy and Safety of Repeated Dosage

People with cervical dystonia (CD) that is type A resistant and responsive have been successfully treated for short periods of time with botulinum toxin type B (Myobloc®). Myobloc has also been shown in been shown to be the clinical equivalent of Botox® (botulism toxin Type A) in a comparative clinical trial using 10,000 U of Myobloc and 150 U of Botox.)

But what is the effect of long-range treatments, and would such long-range treatment be safe?

While many scientific and medical studies have demonstrated the effectiveness of short-range treatment, little information exists concerning such longer treatment. But a recent medical trial gives some answers that may be of interest to people with CD (also referred to as Spasmodic Torticollis, or ST for short) who are both type A resistant and type A responsive.

The long-term safety and efficacy study was conducted by four medical experts in movement disorders from the Albany Medical Center in Albany, NY – Stewart A. Factor, DO; Eric S. Molho, MD; Sharon Evans, LPN, and Paul J. Feustel, PhD. In the clinical trials, 34 patients with CD were recruited and enrolled based on several criteria.

If part, they all

Had participated in previous clinical trials involving botulinum toxin type B;

Were all over 18 years old;

Had a confirmed diagnosis of CD for at least one year, and

Scored greater than 20 on the TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale.) The TWSTRS scale measures the ability to perform certain functions and the severity of pain in people with CD.

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In the trial, patients were first injected with 10,000 units of botulinum toxin type B by neurologists who were familiar with treating CD patients. Subsequent treatments

were increased to an optimum maximum level of as much as 25,000 units. Optimal doses were decided based on patient satisfaction and the side effects of the medicine.

Patient responsiveness was recorded by an independent medical analyst other than the physician doing the clinical study.

Thirty of the 34 patients completed at least five doses (approximately 15 months of treatment), and 28 completed 10 sessions (approximately 30 months of treatment). Four of the six who did not complete 10 sessions of therapy dropped out of the trials.

Responsiveness to therapy in neurological diseases is always difficult to precisely measure because it usually depends on subjective patient self-evaluations. However, based on the TWSTRS scale, patient response improved over the 10 sessions, but the improvement was not as dramatic with each new dose after the fourth session. Patients who had previously responded to Type A in the study perceived their improvements on Type B to be greater, while patients previously resistant to Type A saw slightly less improvement with Type B.

Dry mouth reports in the patients decreased during the trial, while neck weakness and flu-like symptoms increased. Some instances of headache, heartburn, blurred vision, dry eyes, and dizziness were reported.

The medical experts conducting the study concluded that long-term treatment is effective in decreasing the symptoms of CD, although those improvements are less-dramatic with each dose. There were no significant safety issues. The full contents of the article can be found in the medical journal Movement Disorders, September 2005.

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For more information on Myobloc, speak to your physician or check the medical website at HYPERLINK “http://www.myobloc.com” www.myobloc.com .

My mom and I wanted to thank you for hosting such a great symposium this year. This was our third year and we are looking forward to next years. E. Mathews