Alcobra reports Phase 3 clinical trial of MDX in adults with ADHD missed primary endpoint.
Alcobra Ltd., a pharmaceutical company focused on the development of new medications to treat patients with cognitive disorders, reported the top-line results from MEASURE, its second Phase 3 clinical trial for the investigational product Metadoxine Extended Release (MDX) for the treatment of ADHD in adult patients. In this trial, MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners’ Adult ADHD Rating Scales (CAARS).
As previously communicated, the top-line data analysis was conducted on the Full Analysis Set (n=283), which includes all randomized subjects with at least one post-baseline efficacy assessment. Consistent with previously conducted studies, MDX was generally well tolerated.
“We are exceedingly disappointed with these top-line results. In the coming weeks, the Company intends to review the full data set from MEASURE. Consequently, we will evaluate our options and communicate our strategic plan to investors,” stated Dr. Yaron Daniely, President and CEO of Alcobra. “We wish to reiterate our sincere appreciation to all of the patients, investigators, and others who aided us in conducting this study.”
(Source: Globe Newswire)
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Filed Under: Drug Discovery