← Back to Search

Other

Ulixacaltamide for Essential Tremor

Phase 3

Recruiting

Research Sponsored by Praxis Precision Medicines

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a clinical diagnosis of ET prior to screening as characterized by postural and action tremor

Has a body mass index (BMI) at Screening between 18 and 40 kg/m2, inclusive.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 weeks (365 days)

Awards & highlights

Study Summary

This trial will test if ulixacaltamide is a safe and effective treatment for essential tremor, with participants given either ulixacaltamide or placebo for 12 wks & eligible for long-term safety study.

Who is the study for?

This trial is for adults with essential tremor (ET) who are on a stable dose of no more than one ET medication, have not used certain drugs like primidone recently, and do not have other conditions that could cause tremors. They must be willing to avoid as-needed ET meds during the study, use contraception if applicable, and have a BMI between 18-40 kg/m2.Check my eligibility

What is being tested?

The trial tests ulixacaltamide against a placebo in patients with essential tremor over 12 weeks to see if it's safe and effective. After this phase, participants can join a longer-term study where everyone gets ulixacaltamide.See study design

What are the potential side effects?

While specific side effects for ulixacaltamide aren't listed here, common ones in trials may include nausea, headache, dizziness or sleepiness. Participants will be monitored closely for any adverse reactions throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Essential Tremor due to my shaking when moving or standing.

Select...

My BMI is between 18 and 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks (365 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 weeks (365 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks (365 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Long-term Safety Study: Number of participants with Adverse Events (AE) and their severity.

Parallel Design: Change from Baseline (CFB) to Week 12 (Day 84) on mADL11

Randomized Withdrawal: The proportion of participants that maintain response, as defined by change in mADL11 score, following randomized withdrawal

Secondary outcome measures

Parallel Design and Randomized Withdrawal: Dominant Hand Archimedes Spiral (Day 1, Day 56, Day 84)

Parallel Design and Randomized Withdrawal: Number of participants with Adverse Events (AE)

Parallel Design: CGI-S Change from Baseline to Day 14, Day 28, Day 56, and Day 70

+15 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Randomized WithdrawalExperimental Treatment2 Interventions

Double-blind Part: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, 42 days of 60 mg Randomized Withdrawal Part: Following double-blind part: 1:1 randomization to placebo or 60 mg ulixacaltamide for 28 days

Group II: Parallel Design: ulixacaltamide armExperimental Treatment1 Intervention

Double-blind Part: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, 70 days of 60 mg

Group III: Long-term Safety Study: Parallel Design and Randomized Withdrawal rolloversExperimental Treatment1 Intervention

Open-label Part for patients previously on placebo: Oral dosing, once daily in the morning with titration over 14 days to 60 mg ulixacaltamide: 7 days of 20 mg, 7 days of 40 mg, up to 351 days of 60 mg Open-label Part for patients previously on 60 mg ulixacaltamide: Oral dosing, once daily in the morning up to 365 days 60 mg ulixacaltamide

Group IV: Long-term Safety Study: Essential1 rolloversExperimental Treatment1 Intervention

Open-label Part: Oral dosing, once daily in the morning up to one year (365 days) of 60 mg ulixacaltamide

Group V: Parallel Design: placebo armPlacebo Group1 Intervention

Double-blind Part: Oral dosing, once daily in the morning: 84 days of placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Praxis Precision MedicinesLead Sponsor

9 Previous Clinical Trials

579 Total Patients Enrolled

3 Trials studying Essential Tremor

157 Patients Enrolled for Essential Tremor

Director, Clinical DevelopmentStudy DirectorPraxis Precision Medicines

2 Previous Clinical Trials

133 Total Patients Enrolled

1 Trials studying Essential Tremor

133 Patients Enrolled for Essential Tremor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must one meet to be eligible for this research opportunity?

"This clinical study is enrolling 620 individuals between the ages of 18 to 80 who have been clinically diagnosed with essential tremor. To be eligible, participants must: confirm key inclusion criteria at baseline; possess a body mass index (BMI) between 18 and 40 kg/m2; not receive more than one medication for ET prior to screening and maintain that dose throughout the trial duration; pass negative serum pregnancy tests on Day -28 and Baseline (Day 1); use contraception as defined in the protocol informed consent form (ICF); be assessed by an investigator as suitable candidate based on neurological exam results and medical records consistent with diagnosis, which"

Answered by AI

Could you describe the risks and benefits of using ulixacaltamide within a Parallel Design context?

"Our experts at Power have assessed the safety of ulixacaltamide to be a 3, due to its Phase 3 status and existing data attesting to its efficacy and security."

Answered by AI

What is the primary intent of this clinical investigation?

"This trial is monitored for a period of 84 days and aims to assess the proportion of participants that maintain their response after randomized withdrawal. Secondary objectives include establishing the number of adverse events, changes from baseline in clinician-assessed (CGI-S) severity scores, and participant global impressions (PGI-C)."

Answered by AI

Is there still capacity for more participants in this experiment?

"Affirmative. According to the clinicaltrials.gov website, this medical trial is actively seeking participants and was initially posted on November 2nd 2023. An update occurred six days later, on November 7th 2023; 620 patients must be recruited from one location."

Answered by AI

Could you tell me the upper limit of enrollees in this clinical trial?

"Correct. Records on clinicaltrials.gov verify that this medical study, uploaded initially on November 2nd 2023, is still recruiting participants. 620 individuals need to be enrolled from one distinct site."

Answered by AI

Are individuals aged below seventy capable of participating in this research?

"This medical study requires that patients enrolled are aged between 18 and 80 years old. Additionally, there is a sub-trial for those under the age of 18 as well as another specifically targeting individuals over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)

2023. "Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087276.

All > Paid Studies Pittsburgh > Essential Tremor