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# Praxis to Finish Study Despite Data Miss
- URL: https://www.fdaweb.com/praxis-to-finish-study-despite-data-miss/
- Published: 2025-02-28T12:00:00.000Z
- Updated: 2026-09-14T14:54:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158748

Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis that recommended Study 1 of the Essential3 program evaluating ulixacaltamide in essential tremor be stopped for futility because it is unlikely to meet the primary efficacy endpoint under the parameters set by its statistical model. An independent data monitoring committee also indicated that some underlying assumptions of the statistical model might have influenced this outcome and encouraged Praxis to explore alternative analysis methods, the company says.

Praxis says it has decided to continue Study 1 and Study 2 to completion, with topline results expected in the third quarter. “The decision about whether the data supports the submission of an NDA will be made after analyzing the final results for Study 1 and Study 2,” it adds.

“We are disappointed with and surprised by the outcome of the interim analysis for Study 1,” Praxis says. “Following the advice of the committee, we will explore different analysis methods for the final dataset, which is expected in the third quarter of 2025.”