Back to resultsA Clinical Trial of PRAX-944 in Participants With Essential Tremor
Primary Purpose
Essential Tremor
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Part A: 20 and 40 mg PRAX-944
Part B: 120 mg PRAX-944
Part B: 120 mg PRAX-944 and Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Movement Disorder, Benign Essential Tremor, Familial Tremor, Hereditary Essential Tremor, Movement Disorder Agents, Calcium Channels, T-type
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of ET consistent with Movement Disorders Society Criteria, a duration of ET of at least 3 years and with onset before the age of 65
- TETRAS upper limb score (ie, sum of bilateral upper limb items 4a, 4b, and 4c) of ≥10 as rated by the Investigator at Screening and Baseline OR A score of ≥2 on 2 or more of the following TETRAS activities of daily living (ADL) subscale items: (2) Feeding with a spoon, (3) Drinking from a glass, (5) Dressing, (6) Pouring, (9) Writing OR A score of ≥2 on 1 of the following TETRAS ADL subscale items: (2) Feeding with a spoon, (3) Drinking from a glass, (5) Dressing, (6) Pouring, or (9) Writing AND a score of ≥2 on both of the following TETRAS ADL subscale items: (10) Working and (12) Social Impact
- If currently receiving any medication for ET, is on a stable dose of any of these medications for ET for 28 days prior to Screening and is willing to maintain stable doses throughout the trial. If receiving primidone for ET, is willing and able to discontinue 14 days prior to Day 1.
- Body mass index (BMI) between 18 and 40 kg/m2 (inclusive).
Exclusion Criteria:
- Sporadically using a benzodiazepine, sleep medication, or anxiolytic that would confound the assessment of tremor.
- Trauma to the nervous system within 3 months preceding the onset of tremor.
- History of other medical, neurological or psychiatric condition that may explain or cause tremor, including but not limited to Parkinson's disease, dystonia, cerebellar disease, family history of Fragile X syndrome, traumatic brain injury, alcohol abuse or withdrawal, benzodiazepine abuse or withdrawal, multiple sclerosis, polyneuropathy, and endocrine states such as hyperthyroidism.
- Prior magnetic resonance-guided focused ultrasound or surgical intervention for ET such as deep brain stimulation or thalamotomy.
- Botulinum toxin injection for ET in the 6 months prior to Screening.
- Unwilling or unable to refrain from alcohol 24 hours before and during clinical trial visits.
- History of substance use disorder
Sites / Locations
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
- Praxis Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Part A: Open-label 20 and 40 mg PRAX-944
Part B: Open-label titration PRAX-944 (120 mg) followed by blinded PRAX-944
Part B: Open-label titration PRAX-944 (120 mg) followed by blinded placebo
Arm Description
Once daily, oral dosing with 7 days of 20 mg and 7 days of 40 mg
Once daily, oral dosing with titration to 120 mg: 3 days of 20 mg, 4 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 7 days of 100 mg, 28 days of 120 mg
Once daily, oral dosing with titration to 120 mg: 3 days of 20 mg, 4 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 7 days of 100 mg, 14 days of 120 mg, 14 days placebo
Outcomes
Primary Outcome Measures
Part A: Change from baseline to Day 7 and Day 14 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score
The TETRAS is a performance and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the TETRAS PS. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity.
Part B: Incidence and severity of Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Part B: Incidence of AEs by preferred term
The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals), and Columbia-Suicide Severity Rating Scale (C-SSRS) responses.
Secondary Outcome Measures
Part A: Change from baseline to Day 7 and Day 14 on the Essential Tremor Rating Assessment Scale (TETRAS) Performance subscale
The TETRAS is an essential tremor and activities of daily living rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. These 9 items are rated on a 5-point scale (ranging from 0 to 4). One item, Item 4, consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the 9 items (14 ratings) ranges from 0 to 70 with higher scores indicating greater tremor severity. The total score and individual item ratings will be evaluated as outcomes in this trial.
Part A: Change from baseline to Day 7 and Day 14 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score measured by accelerometry
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity. This outcome will be measured by accelerometry with measurements of rotations and accelerations in 3D space over time converted into ratings according to the scale outlined above.
Part A: Incidence of AEs by preferred term
The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals), and Columbia-Suicide Severity Rating Scale (C-SSRS) responses.
Part A: Incidence and severity of Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Part B: Change from baseline to Day 42 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity.
Part B: Change from baseline to Day 7 and Day 21 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity.
Part B: Change from baseline to Day 7, Day 21, and Day 42 on the Essential Tremor Rating Assessment Scale (TETRAS) Performance subscale
The TETRAS is an essential tremor and activities of daily living rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. These 9 items are rated on a 5-point scale (ranging from 0 to 4). One item, Item 4, consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the 9 items (14 ratings) ranges from 0 to 70 with higher scores indicating greater tremor severity. The total score and individual item ratings will be evaluated as outcomes in this trial.
Part B: Change from baseline to Day 7, Day 21, and Day 42 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score measured by accelerometry
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity. This outcome will be measured by accelerometry with measurements of rotations and accelerations in 3D space over time converted into ratings according to the scale outlined above.
Part B: Change from baseline to Day 7, Day 21, and Day 42 on the TETRAS Activities of Daily Living (ADL) score
The TETRAS is an essential tremor and ADL rating scale. The full scale has 2 sections, the Performance subscale and the ADL subscale. The ADL subscale consists of 12 items measuring the impact of essential tremor on typical daily activities. These 12 items are rated on a 5-point scale (ranging from 0 to 4). The total score of the 12 items ranges from 0 to 60 with higher scores indicating greater tremor severity.
Part B: Change from baseline to Day 7, Day 21, and Day 42 on the Quality of Life in Essential Tremor Questionnaire (QUEST) total and subscale scores.
The QUEST is a brief, 30-item, patient-reported ET-specific quality of life scale. The scale contains 5 subscales that cover physical, psychosocial, communication, hobbies/leisure, and work/finance dimensions. The individual items are rated either on a 5-level Likert scale from 0 to 4 (never, rarely, sometimes, frequently, always) or a 2-level scale from 0 (no) to 4 (yes) relative to the respondent's current situation. Five items could also be rated as not applicable. Respondents are also asked to indicate which tremor was perceived to impact a function or be associated with the feeling or attitude in question. The QUEST total and subscale scores are calculated as the sum of all applicable items divided by the number of applicable items times 100. Higher scores indicate greater impact of tremor on quality of life.
Full Information
NCT ID
NCT05021978
First Posted
August 20, 2021
Last Updated
July 20, 2022
Sponsor
Praxis Precision Medicines
Collaborators
Praxis Precision Medicines Australia Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05021978
Brief Title
A Clinical Trial of PRAX-944 in Participants With Essential Tremor
Official Title
A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults With Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
March 24, 2022 (Actual)
Study Completion Date
March 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Praxis Precision Medicines
Collaborators
Praxis Precision Medicines Australia Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 2-part clinical trial to evaluate the efficacy, safety, and tolerability of 40 and 120 mg oral PRAX-944 compared to placebo in the treatment of adults with essential tremor. Part A is designed to study the dose titration from 20 to 40 mg every morning (QAM) (ie, 2 weeks with 7 days at each dose level). Part B is designed to study the dose titration from 20 to up to 120 mg QAM with at least 14 days of dosing at the highest tolerated dose for each participant. Blood levels of PRAX-944 will also be measured throughout the trial and pharmacokinetics will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Movement Disorder, Benign Essential Tremor, Familial Tremor, Hereditary Essential Tremor, Movement Disorder Agents, Calcium Channels, T-type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Part A: Single group Part B: Parallel group, randomized withdrawal
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Part A: Open label Part B: Open label titration followed by quadruple-blind, randomized withdrawal
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: Open-label 20 and 40 mg PRAX-944
Arm Type
Experimental
Arm Description
Once daily, oral dosing with 7 days of 20 mg and 7 days of 40 mg
Arm Title
Part B: Open-label titration PRAX-944 (120 mg) followed by blinded PRAX-944
Arm Type
Experimental
Arm Description
Once daily, oral dosing with titration to 120 mg: 3 days of 20 mg, 4 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 7 days of 100 mg, 28 days of 120 mg
Arm Title
Part B: Open-label titration PRAX-944 (120 mg) followed by blinded placebo
Arm Type
Active Comparator
Arm Description
Once daily, oral dosing with titration to 120 mg: 3 days of 20 mg, 4 days of 40 mg, 7 days of 60 mg, 7 days of 80 mg, 7 days of 100 mg, 14 days of 120 mg, 14 days placebo
Intervention Type
Drug
Intervention Name(s)
Part A: 20 and 40 mg PRAX-944
Intervention Description
Once daily oral treatment
Intervention Type
Drug
Intervention Name(s)
Part B: 120 mg PRAX-944
Intervention Description
Once daily oral treatment with titration
Intervention Type
Drug
Intervention Name(s)
Part B: 120 mg PRAX-944 and Placebo
Intervention Description
Once daily oral treatment with titration followed by placebo
Primary Outcome Measure Information:
Title
Part A: Change from baseline to Day 7 and Day 14 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score
Description
The TETRAS is a performance and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the TETRAS PS. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity.
Time Frame
7 days, 14 days
Title
Part B: Incidence and severity of Adverse Events (AE)
Description
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Time Frame
56 days
Title
Part B: Incidence of AEs by preferred term
Description
The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals), and Columbia-Suicide Severity Rating Scale (C-SSRS) responses.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Part A: Change from baseline to Day 7 and Day 14 on the Essential Tremor Rating Assessment Scale (TETRAS) Performance subscale
Description
The TETRAS is an essential tremor and activities of daily living rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. These 9 items are rated on a 5-point scale (ranging from 0 to 4). One item, Item 4, consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the 9 items (14 ratings) ranges from 0 to 70 with higher scores indicating greater tremor severity. The total score and individual item ratings will be evaluated as outcomes in this trial.
Time Frame
7 days, 14 days
Title
Part A: Change from baseline to Day 7 and Day 14 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score measured by accelerometry
Description
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity. This outcome will be measured by accelerometry with measurements of rotations and accelerations in 3D space over time converted into ratings according to the scale outlined above.
Time Frame
7 days, 14 days
Title
Part A: Incidence of AEs by preferred term
Description
The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals), and Columbia-Suicide Severity Rating Scale (C-SSRS) responses.
Time Frame
14 days
Title
Part A: Incidence and severity of Adverse Events (AE)
Description
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Time Frame
14 days
Title
Part B: Change from baseline to Day 42 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score
Description
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity.
Time Frame
42 days
Title
Part B: Change from baseline to Day 7 and Day 21 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score
Description
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity.
Time Frame
7 days, 21 days
Title
Part B: Change from baseline to Day 7, Day 21, and Day 42 on the Essential Tremor Rating Assessment Scale (TETRAS) Performance subscale
Description
The TETRAS is an essential tremor and activities of daily living rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. These 9 items are rated on a 5-point scale (ranging from 0 to 4). One item, Item 4, consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the 9 items (14 ratings) ranges from 0 to 70 with higher scores indicating greater tremor severity. The total score and individual item ratings will be evaluated as outcomes in this trial.
Time Frame
7 days, 21 days, 42 days
Title
Part B: Change from baseline to Day 7, Day 21, and Day 42 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score measured by accelerometry
Description
The TETRAS is an essential tremor and activities of daily living (ADL) rating scale. The full scale has 2 sections, the Performance subscale (PS) and the ADL subscale. The PS consists of 9 items covering different body regions. The TETRAS upper limb score is item 4 of the upper limb body region. This item is rated on a 5-point scale (ranging from 0 to 4). This item consists of ratings for 3 tasks rated separately for upper limbs on both sides of the body for a total of 6 ratings. The total score of the item ranges from 0 to 24 with higher scores indicating greater tremor severity. This outcome will be measured by accelerometry with measurements of rotations and accelerations in 3D space over time converted into ratings according to the scale outlined above.
Time Frame
7 days, 21 days, 42 days
Title
Part B: Change from baseline to Day 7, Day 21, and Day 42 on the TETRAS Activities of Daily Living (ADL) score
Description
The TETRAS is an essential tremor and ADL rating scale. The full scale has 2 sections, the Performance subscale and the ADL subscale. The ADL subscale consists of 12 items measuring the impact of essential tremor on typical daily activities. These 12 items are rated on a 5-point scale (ranging from 0 to 4). The total score of the 12 items ranges from 0 to 60 with higher scores indicating greater tremor severity.
Time Frame
7 days, 21 days, 42 days
Title
Part B: Change from baseline to Day 7, Day 21, and Day 42 on the Quality of Life in Essential Tremor Questionnaire (QUEST) total and subscale scores.
Description
The QUEST is a brief, 30-item, patient-reported ET-specific quality of life scale. The scale contains 5 subscales that cover physical, psychosocial, communication, hobbies/leisure, and work/finance dimensions. The individual items are rated either on a 5-level Likert scale from 0 to 4 (never, rarely, sometimes, frequently, always) or a 2-level scale from 0 (no) to 4 (yes) relative to the respondent's current situation. Five items could also be rated as not applicable. Respondents are also asked to indicate which tremor was perceived to impact a function or be associated with the feeling or attitude in question. The QUEST total and subscale scores are calculated as the sum of all applicable items divided by the number of applicable items times 100. Higher scores indicate greater impact of tremor on quality of life.
Time Frame
7 days, 21 days, 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of ET consistent with Movement Disorders Society Criteria, a duration of ET of at least 3 years and with onset before the age of 65
TETRAS upper limb score (ie, sum of bilateral upper limb items 4a, 4b, and 4c) of ≥10 as rated by the Investigator at Screening and Baseline OR A score of ≥2 on 2 or more of the following TETRAS activities of daily living (ADL) subscale items: (2) Feeding with a spoon, (3) Drinking from a glass, (5) Dressing, (6) Pouring, (9) Writing OR A score of ≥2 on 1 of the following TETRAS ADL subscale items: (2) Feeding with a spoon, (3) Drinking from a glass, (5) Dressing, (6) Pouring, or (9) Writing AND a score of ≥2 on both of the following TETRAS ADL subscale items: (10) Working and (12) Social Impact
If currently receiving any medication for ET, is on a stable dose of any of these medications for ET for 28 days prior to Screening and is willing to maintain stable doses throughout the trial. If receiving primidone for ET, is willing and able to discontinue 14 days prior to Day 1.
Body mass index (BMI) between 18 and 40 kg/m2 (inclusive).
Exclusion Criteria:
Sporadically using a benzodiazepine, sleep medication, or anxiolytic that would confound the assessment of tremor.
Trauma to the nervous system within 3 months preceding the onset of tremor.
History of other medical, neurological or psychiatric condition that may explain or cause tremor, including but not limited to Parkinson's disease, dystonia, cerebellar disease, family history of Fragile X syndrome, traumatic brain injury, alcohol abuse or withdrawal, benzodiazepine abuse or withdrawal, multiple sclerosis, polyneuropathy, and endocrine states such as hyperthyroidism.
Prior magnetic resonance-guided focused ultrasound or surgical intervention for ET such as deep brain stimulation or thalamotomy.
Botulinum toxin injection for ET in the 6 months prior to Screening.
Unwilling or unable to refrain from alcohol 24 hours before and during clinical trial visits.
History of substance use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VP, Clinical Development
Organizational Affiliation
Praxis Precision Medicines
Official's Role
Study Director
Facility Information:
Facility Name
Praxis Research Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Praxis Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Praxis Research Site
City
New Lambton Heights
State/Province
New South Whales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Praxis Research Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Praxis Research Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Praxis Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Praxis Research Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Praxis Research Site
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Praxis Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of PRAX-944 in Participants With Essential Tremor
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