Ulixacaltamide was found to be well tolerated in the Essential1 trial to treat essential tremor. Credit: Steve Buissinne from Pixabay.

Praxis Precision Medicines has reported topline data from the Phase IIb Essential1 trial of ulixacaltamide (PRAX-944) to treat essential tremor (ET).

The placebo-controlled, randomised, dose range finding, double-blind trial has been designed for assessing the safety, tolerability, and efficacy of once-a-day 60mg or 100mg ulixacaltamide treatment against a placebo after 56 days.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

In the trial, 132 ET patients were randomised and treated.

According to the findings, participants who received treatment with ulixacaltamide showed improvement in the modified Activities of Daily Living (mADL) score relative to the placebo.

Additionally, nominal statistically significant improvements were observed in Clinical Global Impression-Severity (CGI-S) and in Patient Global Impression-Change (PGI-C) scores.

Ulixacaltamide was found to be well tolerated in the trial, and there were no new safety findings.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company plans to meet with the FDA and commence a Phase III trial to treat ET in the second half of this year, based on the observed efficacy and safety profile.

Praxis Precision Medicines president and CEO Marcio Souza said: “The results from Essential1 illustrate the clear potential of ulixacaltamide as an effective and well tolerated treatment for people with essential tremor.

“The study showed meaningful improvement in patient’s daily functioning while also providing insights to guide the programme’s advancement to Phase III, including a deeper understanding of endpoints and trial design.

“It’s clear to us, based on these results and prior clinical experience, that ADLs are the preferred endpoint for a registrational study for essential tremor. We look forward to meeting with the FDA to discuss the data and our Phase III plans.”

Fatigue, paraesthesia, constipation, anxiety, feeling abnormal, dizziness, and headache are the most commonly reported treatment emergent adverse events (TEAEs) observed in participants who received treatment with ulixacaltamide.