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| Overall Recruitment Status: Active, currently enrolling |
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| 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 |
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| Region |
Sponsors |
| Mid-Atlantic |
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| Acronym |
KP IRB No. |
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1872129 |
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| Study Type |
Phase |
| Clinical Trial |
Phase II |
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| Study Population Description |
| Adult patients with essential tremor. |
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| Purpose |
| 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. |
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| Detailed Description |
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| Gender |
Age Limit |
| Male & Female |
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- 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.
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TETRAS upper limb score (ie, sum of bilateral upper limb items 4a, 4b, and 4c) of =10 as rated by the Investigator.
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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.
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Body mass index (BMI) between 18 and 40 kg/m2 (inclusive).
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- Sporadically using a benzodiazepine, sleep medication, or anxiolytic that would confound the assessment of tremor.
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Trauma to the nervous system within 3 months preceding the onset of tremor.
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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
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Prior magnetic resonance-guided focused ultrasound or surgical intervention for ET such as deep brain stimulation or thalamotomy.
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Botulinum toxin injection for ET in the 6 months prior to Baseline.
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Cala trio health device for ET in the 14 days prior to Baseline and throughout the study.
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History of substance use disorder
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- Neurology (Neurological Disorders)
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