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A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor

NCT05021991 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2024-03-13

No results posted yet for this study

Summary

This multi-center, randomized, double-blinded, placebo-controlled, dose-range-finding clinical trial (with an optional Extension comprised of an Extension Double-blind (DB) Lead in Period followed by an Extension Open-label (OL) Period) that will assess the efficacy, safety, and tolerability of PRAX 944 in participants aged 18 years or older who have a diagnosis of Essential Tremor (ET) and have had symptoms for at least 3 years.

Conditions

Interventions

DRUG

100 mg PRAX-944

Once daily oral treatment with titration

DRUG

60 mg PRAX-944

Once daily oral treatment with titration

DRUG

Placebo

Once daily oral treatment

DRUG

Flexibly dosed 20 mg to 100 mg PRAX-944

Once daily oral treatment

Sponsors & Collaborators

Principal Investigators

  • Director, Clinical Development · Praxis Precision Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2023-02-09
Completion
2024-02-29
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05021991 on ClinicalTrials.gov