Trial · NCT05021978
A Clinical Trial of PRAX-944 in Participants With Essential Tremor
NCT05021978, Phase 2, Completed, Praxis Precision Medicines; results first posted 2024-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial of PRAX-944 in Participants With Essential Tremor. Trials, record NCT05021978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05021978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of PRAX-944 in Participants With Essential Tremor
- NCT number
- NCT05021978
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Praxis Precision Medicines
- Conditions
- Essential Tremor
- Interventions
- Part A: 20 and 40 mg PRAX-944, Part B: 120 mg PRAX-944, Part B: 120 mg PRAX-944 and Placebo
- First posted
- 2021-08-26
- Last updated
- 2024-03-01
- Results first posted
- 2024-03-01
- Limitations and caveats
- Due to repeated mistakes during the eligibility review process, a Corrective and Preventative Actions (CAPA) report was issued and enrollment at one site was suspended.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Score | Baseline (Day 0), Days 7 and 14 | The TETRAS upper limb score is calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. Baseline is defined as the last non-missing value collected prior to receiving first dose of study drug. Change from baseline will be defined as assessment value minus baseline value. |
| Primary | Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Up to Day 70 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Incidence and Severity of Adverse Events have been reported. |
| Primary | Part B: Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Values and Electrocardiogram Parameters | Up to Day 70 | Vital signs parameters included 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). Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. |
| Primary | Part B: Number of Participants With Suicidal Ideation or Behavior Assessed Using Columbia Suicide Severity Rating Scale (C-SSRS) | Up to Day 70 | The C-SSRS is described as a scale developed at Columbia University that has 2-6 questions each in categories of Suicidal Ideation, Intensity of Ideation, Suicidal Behavior, and Actual Attempts. Four constructs were measured. Severity of Suicidal ideation is rated on a 5-point ordinal scale. Intensity of ideation is comprised of 5 items (frequency, duration, controllability, deterrents, and reason for ideation), each rated on a 5-point ordinal scale. Suicidal behavior is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal self-injurious behavior. Lethality, assesses actual attempts; actual lethality is rated on a 6-point ordinal scale, and if actual lethality is 0, potential lethality of attempts is rated on a 3-point ordinal scale.The higher the C-SSRS score, the higher the suicide risk (ie. worse outcome). |
| Secondary | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale | Baseline (Day 0), Days 7 and 14 | 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. Baseline is defined as the last non-missing value collected prior to receiving first dose of study drug. |
| Secondary | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Score Measured by Accelerometry | Baseline (Day 0), Days 7 and 14 | Accelerometer was used to evaluate record coordinates and accelerations in the 3D space over time. The 3 maneuvers in the upper limb item will be completed for both arms, first for the right arm and then for the left. Each upper limb sub-item is scored on a scale from 0 to 4 including to 0.1 increments. The accelerometer upper limb total score, ranges from 0 to 24. A decrease in score is indicative of improvement. Baseline is defined as the last non-missing value collected prior to receiving first dose of study drug. Change from baseline will be defined as assessment value minus baseline value. |
| Secondary | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Individual Items # 6 (Spiral Drawing) and Items #7 (Handwriting) | Baseline (Day 0), Days 7 and 14 | The TETRAS ADL subscale is a 12-item assessment of typical daily activities that are impacted by tremor. Activities are assessed in the following functional domains: speaking, feeding, drinking, personal hygiene, dressing, writing, and social activity. The impact to each function is rated on a 5-point Likert scale from 0 to 4. The ADL subscale score is calculated as the sum of all 12 items and ranges from 0 to 48 with higher scores reflecting higher impact. Baseline is defined as the last non-missing value collected prior to receiving first dose of study drug. Change from baseline will be defined as assessment value minus baseline value. |
| Secondary | Part A: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Up to Day 21 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Incidence and Severity of Adverse Events have been reported. |
| Secondary | Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Values and Electrocardiogram Parameters | Up to Day 21 | Vital signs parameters included 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). Any change in vital sign abnormalities that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported as an unsolicited adverse event (AE). Any clinically significant abnormality associated with underlying disease does not require reporting as an (S)AE unless judged by the investigator to be more severe than expected for the participant's condition. |
| Secondary | Part A: Number of Participants With Suicidal Ideation or Behavior Assessed Using Columbia Suicide Severity Rating Scale (C-SSRS) | Up to Day 21 | The C-SSRS is described as a scale developed at Columbia University that has 2-6 questions each in categories of Suicidal Ideation, Intensity of Ideation, Suicidal Behavior, and Actual Attempts. Four constructs were measured. Severity of Suicidal ideation is rated on a 5-point ordinal scale. Intensity of ideation is comprised of 5 items (frequency, duration, controllability, deterrents, and reason for ideation), each rated on a 5-point ordinal scale. Suicidal behavior is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal self-injurious behavior. Lethality, assesses actual attempts; actual lethality is rated on a 6-point ordinal scale, and if actual lethality is 0, potential lethality of attempts is rated on a 3-point ordinal scale.The higher the C-SSRS score, the higher the suicide risk (ie. worse outcome). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Score | Baseline (Day 0), Days 7 and 14 | Full Analysis Set (FAS): all participants who took at least 1 dose of study drug and had a valid baseline TETRAS assessment and at least 1 valid post-baseline TETRAS assessment. Only those participants with data available at indicated timepoints have been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Up to Day 70 | Safety Analysis Set included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| PRIMARY | Part B: Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Values and Electrocardiogram Parameters | Up to Day 70 | Safety Analysis Set | participants | NUMBER |
| PRIMARY | Part B: Number of Participants With Suicidal Ideation or Behavior Assessed Using Columbia Suicide Severity Rating Scale (C-SSRS) | Up to Day 70 | FAS population | Participants | NUMBER |
| SECONDARY | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale | Baseline (Day 0), Days 7 and 14 | FAS population. Only those participants with data available at indicated timepoints have been presented. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Score Measured by Accelerometry | Baseline (Day 0), Days 7 and 14 | FAS Population. Only those participants with data available at indicated timepoints have been presented. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Individual Items # 6 (Spiral Drawing) and Items #7 (Handwriting) | Baseline (Day 0), Days 7 and 14 | FAS population. Only those participants with data available at indicated timepoints have been presented. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Up to Day 21 | Safety Analysis Set | participants | NUMBER |
| SECONDARY | Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Values and Electrocardiogram Parameters | Up to Day 21 | Safety Analysis Set | Participants | NUMBER |
| SECONDARY | Part A: Number of Participants With Suicidal Ideation or Behavior Assessed Using Columbia Suicide Severity Rating Scale (C-SSRS) | Up to Day 21 | Safety Analysis Set | Participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Score | Part A: PRAX-944 20mg to 40mg OLT | Change from baseline to Day 7 | -1.427 | 95% Confidence Interval -4.4375 to 1.5845 | Scores on a scale |
| Part A: Change From Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Upper Limb Score | Part A: PRAX-944 20mg to 40mg OLT | Change from baseline to Day 14 | -2.912 | 95% Confidence Interval -4.2779 to -1.5466 | Scores on a scale |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: PRAX-944 20mg to 120mg OLT | Any AE | 15 | participants | |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: PRAX-944 120mg RWD | Any AE | 1 | participants | |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: Placebo RWD | Any AE | 1 | participants | |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: PRAX-944 20mg to 120mg OLT | Related AE | 12 | participants | |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: PRAX-944 120mg RWD | Related AE | 0 | participants | |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: Placebo RWD | Related AE | 1 | participants | |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: PRAX-944 20mg to 120mg OLT | AE Leading to Treatment Discontinuation | 6 | participants | |
| Part B: Number of Participants With Adverse Events (AE), Related AE, and AE Leading to Treatment Discontinuation | Part B: PRAX-944 120mg RWD | AE Leading to Treatment Discontinuation | 0 | participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| PART A OLT Phase (Day 1 to Day 21) | STARTED | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 7 | |
| PART A OLT Phase (Day 1 to Day 21) | STARTED | Part B: PRAX-944 20mg to 120mg OLT | 0 | |
| PART A OLT Phase (Day 1 to Day 21) | STARTED | Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD) | 0 | |
| PART A OLT Phase (Day 1 to Day 21) | STARTED | Part B: Placebo RWD | 0 | |
| PART A OLT Phase (Day 1 to Day 21) | COMPLETED | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 6 | |
| PART A OLT Phase (Day 1 to Day 21) | COMPLETED | Part B: PRAX-944 20mg to 120mg OLT | 0 | |
| PART A OLT Phase (Day 1 to Day 21) | COMPLETED | Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD) | 0 | |
| PART A OLT Phase (Day 1 to Day 21) | COMPLETED | Part B: Placebo RWD | 0 | |
| PART A OLT Phase (Day 1 to Day 21) | NOT COMPLETED | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 1 | |
| PART A OLT Phase (Day 1 to Day 21) | NOT COMPLETED | Part B: PRAX-944 20mg to 120mg OLT | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events184
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Photophobia | Eye disorders | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 0 | 7 | |
| other | Photophobia | Eye disorders | Part B: PRAX-944 20mg to 120mg OLT | 1 | 17 | |
| other | Photophobia | Eye disorders | Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD) | 0 | 6 | |
| other | Photophobia | Eye disorders | Part B: Placebo RWD | 0 | 5 | |
| other | Anal pruritus | Gastrointestinal disorders | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 0 | 7 | |
| other | Anal pruritus | Gastrointestinal disorders | Part B: PRAX-944 20mg to 120mg OLT | 1 | 17 | |
| other | Anal pruritus | Gastrointestinal disorders | Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD) | 0 | 6 | |
| other | Anal pruritus | Gastrointestinal disorders | Part B: Placebo RWD | 0 | 5 | |
| other | Constipation | Gastrointestinal disorders | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 0 | 7 | 0 |
| other | Constipation | Gastrointestinal disorders | Part B: PRAX-944 20mg to 120mg OLT | 6 | 17 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 0 | 7 |
| Total, all-cause mortality | Part B: PRAX-944 20mg to 120mg OLT | 0 | 17 |
| Total, all-cause mortality | Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD) | 0 | 6 |
| Total, all-cause mortality | Part B: Placebo RWD | 0 | 5 |
| Total, other adverse events | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 6 | 7 |
| Total, other adverse events | Part B: PRAX-944 20mg to 120mg OLT | 15 | 17 |
| Total, other adverse events | Part B: PRAX-944 120mg Randomized Withdrawal Phase (RWD) | 1 | 6 |
| Total, other adverse events | Part B: Placebo RWD | 1 | 5 |
| Total, serious adverse events | Part A: PRAX-944 20mg to 40mg Open-Label Titration (OLT) | 0 | 7 |
| Total, serious adverse events | Part B: PRAX-944 20mg to 120mg OLT | 1 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Spiral Drawing Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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