Clinical Trials Resource Center

New Medical Therapies™

Speech Disorders

Patient Medical Areas

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.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.