Tremor, EssentialPhase 2NCT05234762
Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients With Essential Tremors
A Phase 2 study testing ES-481 in people with Tremor, Essential, run by ES Therapeutics Australia Pty Ltd at 1 site in Canada.
Trial summary
This Pilot Phase 2A study will investigate the safety, tolerability, and pharmacokinetics (PK) of ES-481 in adult patients with essential tremor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tremor, Essential
- What is being tested?
- ES-481
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2021to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written and Signed Informed Consent
- Age 18 to 75 years old
- The Subject must have Essential Tremor (ET). ET is defined as at least 1 upper extremity with a tremor score ≥ 1.5 in forward posture, wing beating posture, or finger-to-nose movement using the Performance subscale of The Essential Tremor Rating Assessment Scale (as per by the Tremor Investigation Group criteria).
- Subject has a diagnosis of essential tremor, as defined by all the following criteria: (a) isolated tremor syndrome consisting of bilateral upper limb action; (b) at least three years duration; (c) with or without tremor in other location (e.g., head, voice, or lower limb).
- The Subject must be on stable dose of anti-tremor medication in the four (4) weeks prior to screening and must willing to maintain their current dose for the duration of the study.
- The Subject had no prior surgery for tremor.
Show all 9Show fewer
- The Subject had no botulinum injection for at least six (6) months prior to -screening.
- The Subject does not have a significant imbalance or risk fall.
- The Subject has not previously taken perampanel.
Who cannot join
- Subjects will be excluded from 7-day screening period or study enrollment into the Treatment Period 1, if they meet any of the following criteria:
- Unwilling or inability to follow the procedures specified by the protocol
- Pregnancy or breast feeding
- Women of child-bearing potential and men who are unable or unwilling to take adequate contraceptive precautions, including one of the following:
- Hormonal contraception (birth control pills, injected hormones, or vaginal ring)
- Intrauterine device
Show all 29Show fewer
- Barrier methods (condom or diaphragm) combined with spermicide
- Surgical sterilization (hysterectomy, tubal ligation, or vasectomy)
- History (within the last year) of illicit drug use or alcohol dependence or a positive screen for alcohol on the Day 1 visit, or a positive screen for drugs of abuse at Screening or at the Day 1 visit
- Subject is unwilling or unable to refrain from alcohol 24 hours before and during clinical trial visits, or regular use of alcohol that would preclude abstinence from alcohol for time periods around visits.
- Subject has a history of substance use disorder consistent with Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria, in the opinion of the Principal Investigator,
- Concomitant treatment with more than three drugs to treat essential tremors
- Subject has had recent exposure (14 days prior to Day 1) to tremorgenic drugs.
- Subject has had direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
- Subject has a history or clinical evidence of other medical, neurological, or psychiatric conditions that may explain or cause tremors, including but not limited to Parkinson's disease, Huntington'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 benzodiazepines abuse or withdrawal, multiple sclerosis, polyneuropathy, and endocrine states such as hyperthyroidism or unstable treatment of hypothyroidism or medication, food, or supplement induced movement disorder (e.g., tremor related to beta agonists or caffeine), or other medical, neurological or psychiatric condition that may explain or cause tremors.
- Subject has had a previous procedure for the treatment of ET, deep brain stimulation, brain lesioning, or magnetic resonance (MR)-guided procedure, e.g., MR-guided focused ultrasound.
- Subject has historical or clinical evidence of tremor with psychogenic origin (including but not limited to eating disorders, major depression, etc.).
- Subject has history of suicidal behavior within 2 years or is currently at risk for suicide in the opinion of the investigator.
- Subject has any neurological abnormality other than ET upon neurological exam, including dystonia, ataxia, or any other neurodegenerative disease, including multiple sclerosis.
- Subject has alkaline phosphatase, aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) level >3.0 x upper limit of normal (ULN) at Screening and/or at Pre-dose.
- Subject has serum creatinine >120 μmol/L and/or creatinine clearance <60 mL/min (according to Cockcroft-Gault formula) at Screening.
- Subject has a history of Long QT syndrome and/or QTcF (Fridericia's correction) interval >450 msec (males) or >470 msec (females) per 12-lead ECG done at Screening.
- Subject has a diagnosis of epilepsy or any history of seizure as an adult; head trauma, stroke, transient ischemic attack within 1 year prior to Screening; unexplained loss of consciousness within 1 year prior to Screening; or any lifetime history of asymptomatic or symptomatic orthostatic hypotension (e.g., postural syncope)
- Subject has a history of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class 3 or 4), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to screening.
- Subject has any major psychiatric disorder that is uncontrolled (for the past 90 days) that, per the Investigator's judgment, can interfere with any of the study procedures.
- Subject should not have received treatment with another investigational drug within 30 days or 5 half-lives (whichever is longer), prior to the screening visit.
- Subject should not have received a vaccine within 60 days prior to study drug administration, except for vaccines related to Covid-19.
- Subject should not have donated or lost more than 450mL of blood or received a transfusion of any blood or blood products within 90 days prior to screening, or donated plasma within 7 days prior to admission.
- Subject has a known allergy to ES-481 or its excipients.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Clinique Neuro-Levis
Lévis, Quebec
Manon Bouchard
About this study
Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients With Essential Tremors
This Pilot Phase 2A study will investigate the safety, tolerability, and pharmacokinetics (PK) of ES-481 in adult patients with essential tremor.
- Conditions
- Tremor, Essential
- Being tested
- ES-481, Placebo
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES-481Drug
Dose escalation during two Treatment Periods
PlaceboOther
Placebo dosed at same dosing as ES-481
| Study group | Role | What they receive |
|---|---|---|
| ES-481 | Experimental | Week 1 - 25 mg qd (2 x 25 mg capsule in the mornings Days 1 to 7 in Treatment Period 1 and Days 44 to 50 in Treatment Period 2) Week 2 - 50 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 8 to 14 in Treatment Period 1 and Days 51 to 57 in Treatment Period 2) Week 3 - 75 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 15 to 21 in Treatment Period 1 and Days 58 to 64 in Treatment Period 2) Week 4 - 75 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 22 to 28 in Treatment Period 1 and Days 65 to 71 in Treatment Period 2) Receives: Drug: ES-481 |
| Placebo | Placebo comparator | Placebo will be dosed at the same quantity and frequency as ES-481 just as Placebo HPMC capsules Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P)
To evaluate postural and kinetic tremor of body parts affected by ET, with emphasis on upper extremity tremor. Items are scored from 0 to 4, with 4 representing the highest severity.
Measured: Collected during 6 days throughout the study, scores to be combined.
Number of participants with abnormal laboratory test results
Collection of: Total protein
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Sodium
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Potassium
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Calcium
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Chloride
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Albumin
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Glucose
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Blood urea nitrogen (BUN)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Creatinine
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Carbon dioxide (CO2)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Uric acid
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Total bilirubin
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Alkaline phosphatase (AP)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: AST
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: ALT
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Gamma-glutamyl transpeptidase (GGT)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Lactate dehydrogenase (LDH)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Creatine phosphokinase (CPK)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Hemoglobin
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Hematocrit
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Red blood cell (RBC) count
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: White blood cell (WBC) count with differential
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Mean corpuscular volume (MCV)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Mean corpuscular hemoglobin (MCH)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Mean corpuscular hemoglobin (MCHC)
Measured: Through study completion, an average of 78 days.
Number of participants with abnormal laboratory test results
Collection of: Absolute platelet count
Measured: Through study completion, an average of 78 days.
Safety assessments through collection of serious adverse events
Collection of Serious Adverse Events
Measured: Through study completion, an average of 78 days.
Safety assessments through collection of adverse events
Collection of Adverse Events
Measured: Through study completion, an average of 78 days.
Safety assessments through collection of treatment emergent adverse events
Collection of Treatment Emergent Adverse Events
Measured: Through study completion, an average of 78 days.
Plama samples for PK
Will be collected to assess the plasma concentration of ES-481 during the 28-day treatment periods from both ES-481 and Placebo subjects to estimate the PK of ES-481 After the study blind is broken, only the samples from subjects who took ES-481 will be analyzed.
Measured: Will be collected on Days 1, 22, 29, 44, 65, and 72
Secondary outcomes (2)
Activity of Daily Living
Subjects will complete a 12-item (0-4 ratings) Activity of Daily Living questionnaire.
Measured: Will be completed on Days 1 (baseline and prior to administration of study medication on Day 1 in Treatment Period 1), and Days 22, 29, 44 (baseline and prior to administration of study medication on Day 44 in Treatment Period 2), 65, and 72
Subject Global Impression of Change Scale (SGIC)
Subjects will rate overall change with the Subject Global Impression of Change Scale in which change was rated between minus 3 and plus 3, with 1 connoting mild change, 2 moderate change, and 3 marked changes, with minus indicating improvement and plus worsening
Measured: Will be completed on Days 1 (baseline and prior to administration of study medication on Day 1 in Treatment Period 1), and Days 22, 29, 44 (baseline and prior to administration of study medication on Day 44 in Treatment Period 2), 65, and 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start21 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tremor, EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ES Therapeutics Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234762
- Sponsor's protocol ID
- ES-481-C203
- Status last verified
- Mar 2023
- First submitted
- 27 Nov 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients With Essential Tremors
- ClinicalTrials.gov ID
- NCT05234762
- Acronym / sponsor ID
- ES-481-C203
- Conditions
- Tremor, Essential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- ES Therapeutics Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Pilot Phase 2A study will investigate the safety, tolerability, and pharmacokinetics (PK) of ES-481 in adult patients with essential tremor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES-481 | Experimental | Drug: ES-481Week 1 - 25 mg qd (2 x 25 mg capsule in the mornings Days 1 to 7 in Treatment Period 1 and Days 44 to 50 in Treatment Period 2) Week 2 - 50 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 8 to 14 in Treatment Period 1 and Days 51 to 57 in Treatment Period 2) Week 3 - 75 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 15 to 21 in Treatment Period 1 and Days 58 to 64 in Treatment Period 2) Week 4 - 75 mg bid (2 x 25 mg capsule in the mornings and 2 x 25 mg capsules in the evening on Days 22 to 28 in Treatment Period 1 and Days 65 to 71 in Treatment Period 2) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be dosed at the same quantity and frequency as ES-481 just as Placebo HPMC capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written and Signed Informed Consent
- Age 18 to 75 years old
- The Subject must have Essential Tremor (ET). ET is defined as at least 1 upper extremity with a tremor score ≥ 1.5 in forward posture, wing beating posture, or finger-to-nose movement using the Performance subscale of The Essential Tremor Rating Assessment Scale (as per by the Tremor Investigation Group criteria).
- Subject has a diagnosis of essential tremor, as defined by all the following criteria: (a) isolated tremor syndrome consisting of bilateral upper limb action; (b) at least three years duration; (c) with or without tremor in other location (e.g., head, voice, or lower limb).
- The Subject must be on stable dose of anti-tremor medication in the four (4) weeks prior to screening and must willing to maintain their current dose for the duration of the study.
Key exclusion criteria (29 listed)
- Subjects will be excluded from 7-day screening period or study enrollment into the Treatment Period 1, if they meet any of the following criteria:
- Unwilling or inability to follow the procedures specified by the protocol
- Pregnancy or breast feeding
- Women of child-bearing potential and men who are unable or unwilling to take adequate contraceptive precautions, including one of the following:
- History (within the last year) of illicit drug use or alcohol dependence or a positive screen for alcohol on the Day 1 visit, or a positive screen for drugs of abuse at Screening or at the Day 1 visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES-481Dose escalation during two Treatment Periods | Drug | ES-481 |
| PlaceboPlacebo dosed at same dosing as ES-481 | Other | Placebo |
Primary outcome
Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P)
Time frame: Collected during 6 days throughout the study, scores to be combined.
To evaluate postural and kinetic tremor of body parts affected by ET, with emphasis on upper extremity tremor. Items are scored from 0 to 4, with 4 representing the highest severity.
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Total protein
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Sodium
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Potassium
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Calcium
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Chloride
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Albumin
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Glucose
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Blood urea nitrogen (BUN)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Creatinine
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Carbon dioxide (CO2)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Uric acid
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Total bilirubin
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Alkaline phosphatase (AP)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: AST
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: ALT
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Gamma-glutamyl transpeptidase (GGT)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Lactate dehydrogenase (LDH)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Creatine phosphokinase (CPK)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Hemoglobin
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Hematocrit
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Red blood cell (RBC) count
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: White blood cell (WBC) count with differential
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Mean corpuscular volume (MCV)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Mean corpuscular hemoglobin (MCH)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Mean corpuscular hemoglobin (MCHC)
Number of participants with abnormal laboratory test results
Time frame: Through study completion, an average of 78 days.
Collection of: Absolute platelet count
Safety assessments through collection of serious adverse events
Time frame: Through study completion, an average of 78 days.
Collection of Serious Adverse Events
Safety assessments through collection of adverse events
Time frame: Through study completion, an average of 78 days.
Collection of Adverse Events
Safety assessments through collection of treatment emergent adverse events
Time frame: Through study completion, an average of 78 days.
Collection of Treatment Emergent Adverse Events
Plama samples for PK
Time frame: Will be collected on Days 1, 22, 29, 44, 65, and 72
Will be collected to assess the plasma concentration of ES-481 during the 28-day treatment periods from both ES-481 and Placebo subjects to estimate the PK of ES-481 After the study blind is broken, only the samples from subjects who took ES-481 will be analyzed.
2 secondary outcomes
Activity of Daily Living
Time frame: Will be completed on Days 1 (baseline and prior to administration of study medication on Day 1 in Treatment Period 1), and Days 22, 29, 44 (baseline and prior to administration of study medication on Day 44 in Treatment Period 2), 65, and 72
Subject Global Impression of Change Scale (SGIC)
Time frame: Will be completed on Days 1 (baseline and prior to administration of study medication on Day 1 in Treatment Period 1), and Days 22, 29, 44 (baseline and prior to administration of study medication on Day 44 in Treatment Period 2), 65, and 72
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ES-481 in people with Tremor, Essential, run by ES Therapeutics Australia Pty Ltd at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Niecestro, PhD (+1-917-733-5311, rniecestro@estherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P) (time frame: Collected during 6 days throughout the study, scores to be combined.). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.