Clinical trial: A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor (NCT04305275)

Eligibility criteria:
Inclusion Criteria:

          -  Participant has a diagnosis of ET, defined as isolated tremor syndrome consisting of
             bilateral upper limb action tremor for at least 3 years prior to screening, with or
             without tremor in other locations and absence of other neurological signs, such as
             dystonia, ataxia, or parkinsonism, isolated focal tremors (eg, voice, head), task- and
             position-specific tremors, sudden tremor onset or evidence of step-wise deterioration
             of tremor.

          -  Participant scores at least 1.5 for each of the six items that comprise the combined
             total upper limb TETRAS (total performance subscale part 4) with the total score for
             the dominant upper limb (the sum of the three items for either the right or left upper
             limb, whichever is dominant) being at least 5.5, at both Screening and predose on Day
             1.

          -  Participant is willing to discontinue medications taken for the treatment of ET within
             14 days or 5 half-lives prior to receiving IP. Medications taken for the treatment of
             ET that were discontinued prior to receiving IP may be resumed following Day 29.

          -  Participant has no clinically significant findings, as determined by the investigator,
             on Screening and pre-dose Day 1 physical examination including mental state
             examination (MSE) and neurologic examination, 12-lead electrocardiogram (ECG), or
             screening clinical laboratory tests.

        Exclusion Criteria:

          -  Participant has a presence of known causes of enhanced physiological tremor.

          -  Participant has had recent exposure (14 days prior to Day 1) to tremorgenic drugs.

          -  Participant has had direct or indirect injury or trauma to the nervous system within 3
             months before the onset of tremor.

          -  Participant has had a previous procedure for the treatment of ET, deep brain
             stimulation, brain lesioning, or magnetic resonance (MR)-guided procedure, eg,
             MR-guided focused ultrasound.

          -  Participant has historical or clinical evidence of tremor with psychogenic origin
             (including but not limited to eating disorders, major depression, etc.).

          -  Participant has history of suicidal behavior within 2 years or answers "YES" to
             questions 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at
             Screening or at Day 1 or is currently at risk for suicide in the opinion of the
             investigator.

          -  Participant has used any known moderate or strong cytochrome P450 3A4 and/or inducers
             within 14 days or 5 half-lives (whichever is longer) prior to Day 1 or consumed
             grapefruit juice, grapefruit, Seville oranges, pomegranates, tangelos, or St. John's
             Wort or products containing these within 30 days prior to Day 1. Use of mild
             cytochrome inhibitors and/or inducers may be permitted.

          -  Participant has concurrent or recent exposure (14 days or 5 half-lives, whichever is
             longer, prior to the Day 1 visit) to sedative/hypnotic drugs, stimulants,
             highly-caffeinated beverages or dietary supplements containing high doses of caffeine,
             or recent increase above regular daily consumption of caffeine.

          -  Participant currently uses or has used within 14 days or 5 half-lives (whichever is
             longer) prior to Day 1, any prescription or over-the-counter medication that is a
             substrate of the OATP1B1 transporter.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment