A Clinical Trial of 2 Doses of PRAX-944 in Participants With Essential Tremor

Completed · Phase 2 · Has a placebo group

Conditions studied: Essential Tremor

In brief

This multi-center, randomized, double-blinded, placebo-controlled, dose-range-finding clinical trial (with an optional Extension comprised of an Extension Double-blind (DB) Lead in Period followed by an Extension Open-label (OL) Period) that will assess the efficacy, safety, and tolerability of PRAX 944 in participants aged 18 years or older who have a diagnosis of Essential Tremor (ET) and have had symptoms for at least 3 years.

Key facts

Study ID

NCT05021991

Run by

Praxis Precision Medicines

People needed

133

Starts

2021-10-14

Expected to finish

2024-02-29

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Participant has moderate to severe functional impairment due to tremor as determined by the TETRAS and CGI-S.
• 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.
• Body mass index (BMI) between 18 and 40 kg/m² (inclusive).

You may not qualify if…

• 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 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
• 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 Baseline.
• Cala trio health device for ET in the 14 days prior to Baseline and throughout the study.
• History of substance use disorder consistent with Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. Participants with a previous diagnosis of substance use disorder who have been in remission for at least 2 years can participate in the trial.

Where it is running

• Praxis Research Site — Birmingham, Alabama, United States
• Praxis Research Site — Little Rock, Arkansas, United States
• Praxis Research Site — San Diego, California, United States
• Praxis Research Site — Santa Monica, California, United States
• Praxis Research Site — Torrance, California, United States
• Praxis Research Site — Aurora, Colorado, United States
• Praxis Research Site — Boca Raton, Florida, United States
• Praxis Research Site — Gainesville, Florida, United States
• Praxis Research Site — Jacksonville, Florida, United States
• Praxis Research Site — Port Charlotte, Florida, United States
• Praxis Research Site — St. Petersburg, Florida, United States
• Praxis Research Site — Tampa, Florida, United States
• Praxis Research Site — West Palm Beach, Florida, United States
• Praxis Research Site — Chicago, Illinois, United States
• Praxis Research Site — Kansas City, Kansas, United States
• Praxis Research Site — Louisville, Kentucky, United States
• Praxis Research Site — Rockville, Maryland, United States
• Praxis Research Site — Boston, Massachusetts, United States
• Praxis Research Site — Burlington, Massachusetts, United States
• Praxis Research Site — Farmington Hills, Michigan, United States
• Praxis Research Site — Golden Valley, Minnesota, United States
• Praxis Research Site — Las Vegas, Nevada, United States
• Praxis Research Site — New York, New York, United States
• Praxis Research Site — New York, New York, United States
• Praxis Research Site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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