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Replies to post #195421 on Biotech Values
09/29/15 4:24 PM
Revance's Phase 2 trial is an open-label, sequential, dose-escalating study to evaluate the safety, preliminary efficacy and duration of effect of a single treatment of RT002 (RTT150 (Botulinum Toxin Type A) for Injection) for isolated cervical dystonia. Approximately 36 patients with at least moderate cervical dystonia are expected to be enrolled at multiple sites in the United States. There will be three treatment groups of approximately 12 patients each who will be treated with one of three doses of RT002 for injection.
The primary efficacy endpoint of the study is an improvement in dystonia symptoms as measured by change (reduction) from baseline in TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale) total score at four weeks. TWSTRS is a composite scale that covers different features of the cervical dystonia condition. The first part of the scale is based on the physical findings and severity of dystonia, the second part rates the patient's perceived level of disability, and the third part rates the pain. Numerous secondary efficacy endpoints will be measured, including duration of effect and patient-rated quality of life as measured by change from baseline in CDIP (Cervical Dystonia Impact Profile).
All patients will be followed out to nine weeks post-injection. Patients with sustained improvement after this initial period of nine weeks will continue to be assessed for duration of efficacy and other measures until they return to baseline or for up to a total of 24 weeks after treatment.
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