Essential Tremor study: 60 mg ulixacaltamide
Official title Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)
ClinicalTrials.gov ID: NCT06087276
What this study is testing
What is 60 mg ulixacaltamide?
This is an investigational once-daily oral medicine being studied as a potential treatment for essential tremor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ulixacaltamide is safe and works for people with essential tremor.
- Who it's for
- You may be able to join if you have essential tremor and meet the study’s health criteria.
- What's involved
- You will take either ulixacaltamide or a pretend treatment for up to 12 weeks. You will have regular check‑ins to see how you feel and if there are side effects.
- Time commitment
- The study lasts about 12 weeks with several visits during that time.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Has a body mass index (BMI) at Screening of ≥18 kg/m2.
- Has a clinical diagnosis of ET confirmed during screening and characterized by postural and action tremor.
- If currently receiving medication prescribed for ET, must be on ≤1 medications, on stable dose(s) for at least 1 month prior to Screening, and...
- Women of childbearing potential must undertake pregnancy tests, with a documented negative serum pregnancy test at Screening, negative urine...
- Is willing and able to use contraception as defined in the protocol and ICF.
You likely can't join if
- Neuropathy, muscle weakness, arthropathy or other musculoskeletal diagnosis of the upper extremity that impairs dexterity or function.
- Has a known hypersensitivity to any component of the formulation of ulixacaltamide.
- Is unwilling or unable to refrain from episodic use of medication(s)/substance(s) that might interfere with the evaluation of tremor during the study.
- Is sporadically using a benzodiazepine, sleep medication or anxiolytic (as further defined in the protocol), that in the judgement of the...
- Has trauma to the nervous system within 3 months preceding the onset of tremor.
- Has a history of unilateral tremor or clinical evidence of another medical, neurological, or psychiatric condition that may explain or cause tremor...
See the full eligibility criteria
Who can join
- Has a body mass index (BMI) at Screening of ≥18 kg/m2.
- Has a clinical diagnosis of ET confirmed during screening and characterized by postural and action tremor.
- If currently receiving medication prescribed for ET, must be on ≤1 medications, on stable dose(s) for at least 1 month prior to Screening, and willing to maintain stable dose(s) throughout the study.
- Women of childbearing potential must undertake pregnancy tests, with a documented negative serum pregnancy test at Screening, negative urine pregnancy tests at Baseline (Day 1) prior to administration of study drug...
- Is willing and able to use contraception as defined in the protocol and ICF.
- Has been assessed as an appropriate and suitable candidate by investigator and has a neurological exam and medical record(s) consistent with ET diagnosis, as confirmed by the ERC central reviewer.
- Confirm key at Baseline
What rules you out
- Neuropathy, muscle weakness, arthropathy or other musculoskeletal diagnosis of the upper extremity that impairs dexterity or function.
- Has a known hypersensitivity to any component of the formulation of ulixacaltamide.
- Is unwilling or unable to refrain from episodic use of medication(s)/substance(s) that might interfere with the evaluation of tremor during the study.
- Is sporadically using a benzodiazepine, sleep medication or anxiolytic (as further defined in the protocol), that in the judgement of the investigator or sponsor would confound the assessment of tremor.
- Has trauma to the nervous system within 3 months preceding the onset of tremor.
- Has a history of unilateral tremor or clinical evidence of another medical, neurological, or psychiatric condition that may explain or cause tremor, including but not limited to Parkinson's disease, Huntington's...
- Has had prior magnetic resonance-guided focused ultrasound or surgical intervention for ET such as a deep brain stimulator (DBS) or lesion therapy such as thalamotomy.
- Has had botulinum toxin injection for ET in the 6 months prior to Screening or throughout the study.
- Is using the Cala trio health device for ET in 14 days prior to Screening or throughout the study.
- Is unwilling or unable to refrain from drinking alcohol 24 hours before and during clinical study assessments, or regular use of alcohol that would preclude abstinence from alcohol for this time period around visits.
- Has a history of substance use disorder consistent with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revision (DSM-5-TR) criteria.
- Is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial or within 31 days of the last study drug dose.
- Is currently taking a prescription or non-prescription product(s) and food known to be moderate or strong inhibitors or strong inducers (moderate inducers are not prohibited) of cytochrome P450 (CYP3A4), which cannot be...
- Has received any experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening.
- Has any of the following abnormal test results at Screening: a serum total bilirubin value \>1.5×upper limit of normal (ULN); a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>2×ULN.
- History of human immunodeficiency virus (HIV) infection or positive screening result for: HIV 1 or 2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), or hepatitis C virus antibody...
- History of long QT syndrome and/or a Fridericia formula corrected QT interval (QTcF) interval \>450 msec (males) or \>460 msec (females) per electrocardiogram (ECG) done at Screening.
- Any major psychiatric disorder, including but not limited to depression and anxiety, that is uncontrolled (for the past 90 days) or, in the investigator's judgment, can interfere with any of the study procedures.
- Has a lifetime history of any suicide attempt, or suicidal ideation with intent within the past 2 years prior to Screening.
- Participants with completely excised non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) or cervical carcinoma in situ are permitted at any time.
- Participants with a history of other malignancies deemed cured by adequate treatment are also permitted at any time.
- Has any other significant disease or disorder including but not limited to uncontrolled seizure or epilepsy, diabetes, cardiovascular disease, renal disease, laboratory abnormalities, or environmental factor that, in...
- Participant has a positive alcohol or drug screening (including cannabis and cannabis-derived products).
- History of or evidence of psychogenic tremor
- Prior participation in an ulixacaltamide clinical trial at any time or other clinical trial evaluating a potential drug for ET in the past 6 months (with the exception of participants with documentation that they...
- Has a clinical diagnosis of ET confirmed during screening and characterized by postural and action tremor.
- Women of childbearing potential must undertake pregnancy tests, with a documented negative serum pregnancy test at Screening, negative urine pregnancy tests prior to administration of study drug, throughout the...
- Is willing and able to use contraception.
- Has been assessed as an appropriate and suitable candidate by investigator and has a neurological exam and medical record(s) consistent with ET diagnosis, as confirmed by the ERC central reviewer.
- Has a known hypersensitivity to any component of the formulation of the ulixacaltamide.
- Has trauma to the nervous system within 3 months preceding the onset of tremor.
- Has a history of unilateral tremor or clinical evidence of another medical, neurological, or psychiatric condition that may explain or cause tremor.
- Has deep brain stimulator (DBS) that in the investigator's discretion is associated with significant stimulation side effects that could impact participant safety.
- Has a history of substance use disorder consistent with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revision (DSM-5-TR) criteria.
- Is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial or within 31 days of the last study drug dose.
- Has received any experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening.
- Has any of the following abnormal test results at Screening: a serum total bilirubin value \>1.5×upper limit of normal (ULN); a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>2×ULN.
- History of or active human immunodeficiency virus (HIV) infection or positive screening result for: HIV 1 or 2 antibodies. Evidence of active hepatitis B or hepatitis C infection.
- History of or currently comorbid long QT syndrome and/or a Fridericia formula corrected QT interval (QTcF).
- Any major psychiatric disorder, including but not limited to depression and anxiety, that is uncontrolled (for the past 90 days).
- Has a lifetime history of any suicide attempt, or suicidal ideation with intent within the past 2 years prior to Screening.
- Participants who have a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years prior to screen are excluded.
- Has any other significant disease or disorder including but not limited to uncontrolled seizure or epilepsy, diabetes, cardiovascular disease, renal disease, laboratory abnormalities, or environmental factor.
- Participant has a positive drug screening associated with drug abuse or misuse.
- History of or evidence of psychogenic tremor.
The study team makes the final eligibility decision.
Where it is enrolling
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Morgantown, West Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.