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Calcium Channel Blocker
PRAX-944 for Essential Tremor (Essential1 Trial)
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 56 days
Summary
This trial is testing PRAX 944, a new medication, to see if it can help people with Essential Tremor, a condition that causes uncontrollable shaking. The study includes adults who have had this condition for a significant period. Researchers want to find out if PRAX 944 can reduce the symptoms by affecting certain brain pathways involved in movement.
Eligible Conditions
- Essential Tremor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline to Day 56 on the modified ADL
Secondary study objectives
CGI-I scores at Days 14, 28, and 42
Change from baseline to Day 42 on the TETRAS-PS total score
Change from baseline to Day 56 on the Clinical Global Impression-Severity (CGI-S)
+13 moreOther study objectives
Incidence of AEs by preferred term
Side effects data
From 2022 Phase 2 trial • 24 Patients • NCT0502197835%
Constipation
35%
Dizziness
24%
Cognitive disorder
18%
Insomnia
18%
Fatigue
12%
Paraesthesia
6%
Balance disorder
6%
Cyst
6%
Hallucinations, mixed
6%
Anal pruritus
6%
Disturbance in attention
6%
Somnolence
6%
Dizziness postural
6%
Dry mouth
6%
Migraine
6%
Speech disorder
6%
Erythema
6%
Nausea
6%
Confusional state
6%
Headache
6%
Blood creatinine increased
6%
Swelling face
6%
Hot flush
6%
Hypoaesthesia
6%
Nystagmus
6%
Hypotension
6%
Anxiety
6%
Arthralgia
6%
Head discomfort
6%
Photosensitivity reaction
6%
Muscle fatigue
6%
Increased appetite
6%
Photophobia
6%
Gait disturbance
6%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part B: PRAX-944 20mg to 120mg OLT
Part B: Placebo RWD
Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT)
Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Regimen 2Experimental Treatment4 Interventions
Double-blind Part: Oral dosing, once daily in the morning with titration over 56 days to 60 mg PRAX-944: 7 days of 5 mg, 7 days of 10 mg, 7 days of 20 mg, 7 days of 40 mg, 28 days of 60 mg
Extension Part: Double-blind Lead-in: Oral dosing, once daily in the morning with titration over 43 days to 100 mg PRAX-944: 7 days of 80 mg, 36 days of 100 mg
Extension Part: Open-label Flexible PRAX-944 Dosing: Oral dosing, once daily in the morning of 20 mg to 100 mg PRAX-944 for 469 days
Crossover Part: Following double-blind lead-in/open-label: 1:1 randomization to placebo or stable dose of PRAX-944 for 21 days followed by cross-over to either placebo or PRAX-944 oral dosing, once daily in the morning with titration over 7 days (3 days at 20 mg, 4 days at 40 mg) to 60 mg (14 days) before returning to open-label part.
Group II: Regimen 1Experimental Treatment4 Interventions
Double-blind Part: Oral dosing, once daily in the morning with titration over 56 days to 100 mg PRAX-944: 7 days of 5 mg, 7 days of 10 mg, 7 days of 20 mg, 7 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 14 days of 100 mg
Extension Part: Double-blind Lead-in: Oral dosing, once daily in the morning over 43 days: 100 mg PRAX-944
Extension Part: Open-label Flexible PRAX-944 Dosing: Oral dosing, once daily in the morning of 20 mg to 100 mg PRAX-944 for 469 days
Crossover Part: Following double-blind lead-in/open-label: 1:1 randomization to placebo or stable dose of PRAX-944 for 21 days followed by cross-over to either placebo or PRAX-944 oral dosing, once daily in the morning with titration over 7 days (3 days at 20 mg, 4 days at 40 mg) to 60 mg (14 days) before returning to open-label part.
Group III: Regimen 3Placebo Group4 Interventions
Double-blind Part: Oral dosing, once daily in the morning: 56 days of placebo
Extension Part: Double-blind Lead-in: Oral dosing, once daily in the morning with titration over 43 days to 100 mg PRAX-944: 7 days of 5 mg, 7 days of 10 mg, 7 days of 20 mg, 7 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 14 days of 100 mg
Extension Part: Open-label Flexible PRAX-944 Dosing: Oral dosing, once daily in the morning of 20 mg to 100 mg PRAX-944 for 469 days
Crossover Part: Following double-blind lead-in/open-label: 1:1 randomization to placebo or stable dose of PRAX-944 for 21 days followed by cross-over to either placebo or PRAX-944 oral dosing, once daily in the morning with titration over 7 days (3 days at 20 mg, 4 days at 40 mg) to 60 mg (14 days) before returning to open-label part.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
100 mg PRAX-944
2021
Completed Phase 2
~140
60 mg PRAX-944
2021
Completed Phase 2
~140
Flexibly dosed 20 mg to 100 mg PRAX-944
2021
Completed Phase 2
~140
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Praxis Precision MedicinesLead Sponsor
9 Previous Clinical Trials
1,046 Total Patients Enrolled
3 Trials studying Essential Tremor
624 Patients Enrolled for Essential Tremor
VP, Clinical DevelopmentStudy DirectorPraxis Precision Medicines
7 Previous Clinical Trials
690 Total Patients Enrolled
2 Trials studying Essential Tremor
24 Patients Enrolled for Essential Tremor
Director, Clinical DevelopmentStudy DirectorPraxis Precision Medicines
2 Previous Clinical Trials
600 Total Patients Enrolled
1 Trials studying Essential Tremor
600 Patients Enrolled for Essential Tremor
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