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Double-blind Sequence 2 for Essential Tremor

Phase 2
Waitlist Available
Research Sponsored by Praxis Precision Medicines
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 5, and day 9
Awards & highlights

Study Summary

This is a 2-part clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of PRAX-114 in participants with essential tremor (ET). Part A is a randomized, double-blind, placebo-controlled, three-period, three-sequence, crossover design where participants will receive a single dose of 10 mg PRAX-114, 20 mg PRAX-114, and matching placebo. Part B is an open-label design where participants from Part A, after washout and confirmation of eligibility may elect to participate in Part B where all participants will receive 10 mg once every morning (QAM) for the first 14 days. Based on investigator judgement of the safety and tolerability, the dose for Days 15 to 28 could be increased to 20 mg QAM.

Eligible Conditions
  • Essential Tremor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 5, and day 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 5, and day 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence and severity of Adverse Events (AE)
Part B: Incidence and severity of AEs
Secondary outcome measures
Part A: Change from pre-dose to each post-dose timepoint on the Essential Tremor Rating Assessment Scale (TETRAS) combined upper limb (CUL) score
Part B: Change from baseline to Day 28 on the TETRAS Activities of Daily Living (ADL) subscale scores

Trial Design

4Treatment groups
Experimental Treatment
Group I: Open-label Period PRAX-114Experimental Treatment1 Intervention
Open-label extension period - 10 mg or 20 mg PRAX-114 once daily in the morning for 28 days
Group II: Double-blind Sequence 3Experimental Treatment1 Intervention
Double-blind treatment sequence of placebo, 10 mg, and 20 mg in the morning
Group III: Double-blind Sequence 2Experimental Treatment1 Intervention
Double-blind treatment sequence of 20 mg, placebo, and 10 mg in the morning
Group IV: Double-blind Sequence 1Experimental Treatment1 Intervention
Double-blind treatment sequence of 10 mg, 20 mg, and placebo in the morning

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Who is running the clinical trial?

Praxis Precision MedicinesLead Sponsor
9 Previous Clinical Trials
1,179 Total Patients Enrolled
3 Trials studying Essential Tremor
757 Patients Enrolled for Essential Tremor
VP, Clinical DevelopmentStudy DirectorPraxis Precision Medicines
7 Previous Clinical Trials
823 Total Patients Enrolled
2 Trials studying Essential Tremor
157 Patients Enrolled for Essential Tremor

Frequently Asked Questions

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~0 spots leftby Apr 2025