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Trial record 1 of 1 for:    PRAX-944-222
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A Clinical Trial of 3 Doses of PRAX-944 in Participants With Essential Tremor

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ClinicalTrials.gov Identifier: NCT05021991
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
Praxis Precision Medicines

Brief Summary:
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the tolerability, safety, and efficacy of 20, 60, and 100 mg oral PRAX-944 compared to placebo in the treatment of adults with essential tremor. Blood levels of PRAX-944 will also be measured throughout the trial.

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: 100 mg PRAX-944 Drug: 60 mg PRAX-944 Drug: 20 mg PRAX-944 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Clinical Trial to Evaluate the Tolerability, Safety, and Efficacy of PRAX-944 in the Treatment of Adults With Essential Tremor
Actual Study Start Date : October 14, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRAX-944 (100 mg)
Once daily, oral dosing with titration to 100 mg: 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
Drug: 100 mg PRAX-944
Once daily oral treatment with titration

Experimental: PRAX-944 (60 mg)
Once daily, oral dosing with titration to 60 mg: 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
Drug: 60 mg PRAX-944
Once daily oral treatment with titration

Drug: Placebo
Once daily oral treatment

Experimental: PRAX-944 (20 mg)
Once daily, oral dosing with titration to 20 mg: 7 days of 5 mg, 7 days of 10 mg, 42 days of 20 mg
Drug: 20 mg PRAX-944
Once daily oral treatment with titration

Drug: Placebo
Once daily oral treatment

Placebo Comparator: Placebo
Once daily, oral dosing: 56 days of placebo
Drug: Placebo
Once daily oral treatment




Primary Outcome Measures :
  1. Incidence and severity of Adverse Events (AE) [ Time Frame: 56 days ]
    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.


Secondary Outcome Measures :
  1. Change from baseline to Day 56 on the Essential Tremor Rating Assessment Scale (TETRAS) combined upper limb (CUL) score [ Time Frame: 56 days ]
    The TETRAS is an essential tremor and activities of daily living rating scale. The full scale has 2 sections, the TETRAS Performance subscale (PS) and the TETRAS ADL subscale. The TETRAS PS consists of 9 items covering different body regions. TETRAS CUL aggregates the upper limb items from the TETRAS PS including Items 4, 6, 7 and 8. The total score for the TETRAS CUL ranges from 0 to 44 with higher scores indicating greater tremor severity.

  2. Change from baseline to Day 56 on the TETRAS Activities of Daily Living (ADL) score [ Time Frame: 56 days ]
    The TETRAS 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 48 with higher scores indicating greater tremor severity.

  3. Change from baseline to Day 56 on the TETRAS Modified Total Score [ Time Frame: 56 days ]
    The TETRAS Modified Total Score is comprised of TETRAS ADL and TETRAS PS spirography and handwriting scores.


Other Outcome Measures:
  1. Incidence of AEs by preferred term [ Time Frame: 56 days ]
    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), and electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of ET, including: (a) tremor syndrome of bilateral upper limb action tremor, (b) at least 3 years in duration, (c) with or without tremor in other locations (eg, head, voice, or lower limbs), (d) If the symptoms and signs are judged by the investigator to be due to the diagnosis of ET, it is acceptable for them to also have one or more of the following ET plus signs: (i) mild dystonic posturing, (ii) mild rest tremor in the setting of advanced ET and in the absence of other features of Parkinsonism, (iii) intention tremor, (iv) mild increase in tandem gait difficulty.
  2. TETRAS upper limb score (ie, sum of bilateral upper limb items 4a, 4b, and 4c) of ≥10 as rated by the Investigator.
  3. If currently receiving any medication for ET, is on a stable dose of any of these medications for ET for 1 month 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.
  4. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive).

Exclusion Criteria:

  1. Sporadically using a benzodiazepine, sleep medication, or anxiolytic that would confound the assessment of tremor.
  2. Trauma to the nervous system within 3 months preceding the onset of tremor.
  3. History or clinical evidence of other medical, neurological, or psychiatric condition that may explain or cause tremor, including but not limited to Parkinson's disease, Huntington's disease, Alzheimer's disease, cerebellar disease (including spinocerebellar ataxias), primary dystonia, Fragile X Tremor/Ataxia syndrome or family history of Fragile X syndrome, traumatic brain injury, psychogenic tremor, alcohol or benzodiazepine abuse or withdrawal, multiple sclerosis, polyneuropathy, and endocrine states such as hyperthyroidism or unstable treatment of hypothyroidism or medication, food, or supplement induced movement disorders (eg, tremor related to beta agonists or caffeine), or other medical, neurological, or psychiatric conditions that may explain or cause tremor
  4. Prior magnetic resonance-guided focused ultrasound or surgical intervention for ET such as deep brain stimulation or thalamotomy.
  5. Botulinum toxin injection for ET in the 6 months prior to Baseline.
  6. Cala trio health device for ET in the 14 days prior to Baseline and throughout the study.
  7. History of substance use disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021991


Contacts
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Contact: Chief Medical Officer, Praxis Precision Medicines 617-300-8460 clinicaltrials@praxismedicines.com

Locations
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United States, Alabama
Praxis Research Site Not yet recruiting
Birmingham, Alabama, United States, 35294
United States, Arkansas
Praxis Research Site Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Praxis Research Site Recruiting
San Diego, California, United States, 92103
Praxis Research Site Recruiting
Santa Monica, California, United States, 90404
Praxis Research Site Recruiting
Torrance, California, United States, 90503
United States, Colorado
Praxis Research Site Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Praxis Research Site Recruiting
Boca Raton, Florida, United States, 33486
Praxis Research Site Not yet recruiting
Gainesville, Florida, United States, 32608
Praxis Research Site Recruiting
Jacksonville, Florida, United States, 32209
Praxis Research Site Recruiting
Port Charlotte, Florida, United States, 33980
Praxis Research Site Recruiting
Saint Petersburg, Florida, United States, 33713
Praxis Research Site Recruiting
Tampa, Florida, United States, 33612
Praxis Research Site Completed
West Palm Beach, Florida, United States, 33407
United States, Georgia
Praxis Research Site Not yet recruiting
Atlanta, Georgia, United States, 30329
United States, Illinois
Praxis Research Site Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Kansas
Praxis Research Site Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Praxis Research Site Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
Praxis Research Site Not yet recruiting
Rockville, Maryland, United States, 20852
United States, Massachusetts
Praxis Research Site Recruiting
Boston, Massachusetts, United States, 02118
Praxis Research Site Not yet recruiting
Boston, Massachusetts, United States, 02135
Praxis Research Site Not yet recruiting
Burlington, Massachusetts, United States, 01805
United States, Michigan
Praxis Research Site Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Praxis Research Site Recruiting
Golden Valley, Minnesota, United States, 55427
United States, Nevada
Praxis Research Site Not yet recruiting
Las Vegas, Nevada, United States, 89106
United States, New York
Praxis Research Site Recruiting
New York, New York, United States, 10029
Praxis Research Site Not yet recruiting
New York, New York, United States, 10032
United States, Ohio
Praxis Research Site Recruiting
Cincinnati, Ohio, United States, 45212
Praxis Research Site Not yet recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Praxis Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Praxis Research Site Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Praxis Research Site Recruiting
Georgetown, Texas, United States, 78628
Praxis Research Site Not yet recruiting
Houston, Texas, United States, 77030-4202
Praxis Research Site Not yet recruiting
Houston, Texas, United States, 77030
Praxis Research Site Recruiting
Round Rock, Texas, United States, 78681
United States, Vermont
Praxis Research Site Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Praxis Research Site Recruiting
Alexandria, Virginia, United States, 22311
Praxis Research Site Recruiting
Virginia Beach, Virginia, United States, 23456
United States, Washington
Praxis Research Site Recruiting
Kirkland, Washington, United States, 98034
Praxis Research Site Recruiting
Spokane, Washington, United States, 99202
United States, Wisconsin
Praxis Research Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
Praxis Research Site Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
Praxis Research Site Active, not recruiting
Halifax, Nova Scotia, Canada, B3S 1N2
Canada, Ontario
Praxis Research Site Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Praxis Research Site Not yet recruiting
Montréal, Quebec, Canada, H3A 2B4
Sponsors and Collaborators
Praxis Precision Medicines
Investigators
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Study Director: VP, Clinical Development Praxis Precision Medicines
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Responsible Party: Praxis Precision Medicines
ClinicalTrials.gov Identifier: NCT05021991    
Other Study ID Numbers: PRAX-944-222
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Praxis Precision Medicines:
Movement Disorder
Benign Essential Tremor
Familial Tremor
Hereditary Essential Tremor
Movement Disorder Agents
Calcium Channels, T-type
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Pramoxine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents