The T-CALM study will evaluate whether investigational oral drug CX-8998 decreases the severity of tremors by reducing abnormal activity in certain regions of the brain. The study will utilize a combination of standard clinical trial scales and state-of-the-art digital biomarkers to objectively assess patients’ tremors. The study will also assess side effects of the drug, measure its impact on quality of life and further examine how the drug works.
The study is being conducted with more than 90 participants at multiple medical research centers in the United States. People with essential tremor will participate in the study for up to 10 weeks. Participants in the study will be randomly assigned to one of two groups – half will receive the study drug and the other half will be given a placebo (sugar pill). In order to scientifically assess the effects of the drug, neither the participants nor the clinical team will know during the study what group each patient is in.
Study participation, testing and medication are all free to participants.
What is a clinical trial?
T-CALM is a clinical trial -- a medical research study to explore whether an investigational intervention is safe and effective for humans. The purpose of conducting clinical trials is research, so the trials follow strict scientific standards. These standards protect patients and help produce reliable study results.
Patients with certain medical conditions, as well as healthy individuals, may volunteer to participate in clinical trials to help further medical knowledge and scientific progress.
A clinical trial may find that a new intervention improves patient outcomes, offers no benefit or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care. All new medications like CX-8998 are studied in clinical trials to generate data that can be evaluated by the US Food and Drug Administration (FDA) for safety and effectiveness before being approved for use in the United States.
T-CALM is recruiting more than 90 participants at multiple medical research centers across the United States. If you have been diagnosed with essential tremor, you may be eligible.
Eligibility requirements for the T-CALM Study include:
- Men and women (not pregnant or breastfeeding) 18 to 75 years old
- Diagnosis of essential tremor affecting both hands and arms
- No previous brain surgery, focused ultrasound or deep brain stimulation for tremor
- No known history of other causes of tremor, such as Parkinson’s disease, hyperthyroidism, multiple sclerosis, or head trauma or brain disease in the three months before the tremor began
You may be able to participate in the study even if you are already taking one medication for tremor. (However, people using Primidone will be asked to discontinue it prior to starting the study.) Other eligibility criteria will be reviewed with the study clinical team before proceeding with enrollment.
What does the study involve?
- Screening Visit -- Participants will start with a screening visit to confirm if they have essential tremor and to measure the severity of tremor. The medical staff will take their medical history and perform a physical exam to ensure candidates meet the study requirements.
- Informed Consent -- People who are eligible to participate will receive materials that clearly explain the nature of the study and what is involved. The research site staff will tell you of any known risks or potential side effects. You will be provided with a consent form to review carefully to ensure you fully understand the risks and benefits of your participation before signing.
- Study Group Assignment -- Participants in the study will be randomly assigned to one of two groups – half will receive the study drug (CX-8998) and the other half will be given a placebo (sugar pill). In order to scientifically assess the effects of the drug, neither the participants nor the clinical team will know during the study what group each patient is in.
- Study Initiation -- The first day of the study, participants will take the first oral dose of the study medication and undergo additional testing (including videotape assessments of their tremor).
- Study Visits -- Participants will take the study medication orally for 28 days with incremental increases in dosing and will make multiple scheduled clinic visits for additional assessments and tremor measurement.
- Study Completion -- After the 28 days on study medication, participants will continue in the study for another 7 days without taking the study drugs and then return for the final visit to the clinic for evaluation.
Study participation, testing and medication are all free to participants. Some people may receive stipends to cover meals and travel related to study visits.
About CX-8998
The brain’s neural network utilizes certain calcium channels, called Cav3, that help control neuronal firing and signaling between brain regions. Some neurological diseases, such as essential tremor, are associated with abnormal activity of these signals. CX-8998 is an oral drug that was designed to selectively modulate Cav3 calcium channel activity in the brain’s neurons, acting as a biological ‘pacemaker’ to help restore the brain’s natural rhythms. Scientific data suggest that CX-8998 reduces tremor by suppressing abnormal Cav3 activity and restoring normal neural signaling in relevant brain regions.
CX-8998 has been studied in nearly 200 people, mostly healthy volunteers and some people with other neurological conditions. CX-8998 is being developed by Cavion, a company developing T-type calcium channel (Cav3) modulating therapies for a range of chronic neurological diseases, including essential tremor, Parkinson’s disease, neuropathic pain, and epilepsy.