Brainsway Announces Final Results In Clinical Trial For Smoking Cessation In Chronic Obstructive Pulmonary Disease Patients
JERUSALEM, Jan. 24, 2013 (GLOBE NEWSWIRE) -- Brainsway Ltd. (TASE:BRIN) ("Brainsway" or the "Company) is pleased to announce that it has received final results with respect to a clinical trial that was conducted at the Be'er Ya'akov Mental Health Center to assess the efficacy of the Company's Deep TMS device in inducing smoking cessation in chronic obstructive pulmonary disease ("COPD") patients using a specialized coil developed for this purpose.
A total of 115 patients participated in the study. The trial subjects were divided into three groups: a sham treatment group, a low-frequency real stimulation treatment group and a high-frequency real stimulation treatment group. Half of the subjects in each group were exposed to cigarette cues designed to induce temporary cigarette craving prior to the start of each treatment session. Of these patients, 78 completed the treatment period (including 32 patients who received high-frequency treatment, 14 subjects who received low-frequency treatment and 32 subjects who received sham treatment). The Company noted that, following an interim analysis, follow-up in the low-frequency group was discontinued as no improvement was observed in this group compared with the sham control group.
The primary outcome measure for therapeutic efficacy was the change in patients' cigarette consumption levels, as measured both by self-report and by urinary cotinine (a metabolite of nicotine) levels at the end of the treatment period, and again six months after the end of treatment using only self-report.The results reveal a significant response (greater than 50% reduction in cigarette consumption) to treatment among approximately 81% of the high-frequency stimulation group subjects who were exposed to cigarette cues prior to treatment, compared to 12-29% of subjects in the other groups. Approximately 44% of the subjects in the high-frequency stimulation group that were exposed to cigarette cues before each treatment session achieved total smoking cessation. Approximately 84% of these subjects who achieved total smoking cessation at the end of the trial persisted in their abstinence six months after the end of the trial (as determined by self-report). A similar trend was revealed in subjects' cigarette dependence levels, as measured by the Fagerström Test for Nicotine Dependence (FTND).
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