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May 29, 2006
Indevus announced positive results of a phase II trial of pagoclone for the treatment of persistent developmental stuttering. Results from the study met their primary efficacy endpoints, significantly improving scores on the SSI-3 diagnostic scale at weeks 4 and 8 (p=0.02), and the SSS severity sub-score at weeks 2 (p=0.004) and 4 (p=0.05), with an additional trend towards improvement at week 8 (p=0.08), compared to placebo. Numerical, non-significant superiority was also noted on the SEV diagnostic scale at weeks 2, 4 and 8 (p=0.18). Significant efficacy was also noted in a number of secondary endpoints, including the CGI-I at weeks 4 (p=0.007) and 8 (p=0.02), percentage of patients showing improvement at week 8 (55% vs. 35% for placebo), and the LSAS speaking-anxiety subscale at weeks 4 (p=0.02) and 8 (p=0.02); a trend towards significance was noted in total LSAS score at weeks 4 (p=0.09) and 8 (p=0.07). This placebo-controlled, double-blind, multi-center study enrolled 132 subjects, who received escalating doses of the drug (0.3 mg to 0.6 mg) or placebo daily for 8 weeks.