Cavion is committed to pioneering new treatments by testing our technology in compassionately innovative clinical trials that use subject-friendly methods of data collection. We are currently recruiting people with essential tremor for a multi-center clinical trial.  

Have you been diagnosed with essential tremor? Please consider participating in the T-CALM study.

 

About the Study

The T-CALM study will evaluate whether investigational oral drug CX-8998 reduces the severity of tremors by reducing abnormal activity in certain regions of the brain. 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, 18-75 years of age at multiple medical research centers in the United States. People with essential tremor will participate in the study for 5 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 participant is in.

What are volunteers asked to do?

  • Participants will start with a screening visit to confirm if they have essential tremor and to measure the severity of their tremors. The medical staff will take their medical history and perform a physical exam.
  • The first day of the study, participants will take the first oral dose of the study medication and have additional assessments (including videotape assessments of their tremor).
  • 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.
  • After the 28 days on study medication, participants will continue in the study for another 7 days without taking the study medication and then return for the final visit to the clinic for evaluation.  

Eligibility requirements for the T-CALM Study include:

  • Men and women (not pregnant or breastfeeding) 18 to 75 years old
  • Diagnosis prior to age 65 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 3 months before the tremor began

You may be eligible for 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.

About CX-8998

The brain’s neural network has calcium channels, called Cav3, that help control the firing and signaling between neurons. Some neurological disease, such as essential tremor, are associated with abnormal activity of these signals. CX-8998 is an oral drug that was designed to selectively modulate these calcium channels between in the brain’s neurons, acting as a biological ‘pacemaker’ to help regulate neural activity and reduce tremor.

CX-8998 has been studied in nearly 200 people, mostly healthy volunteers, and some people with other neurological conditions.

The safety and efficacy of CX-8998 for treatment of essential tremor have not been established.
 


Participation in the study is free.
 

If you are interested in participating in the T-CALM study, please call 201- 822-5608 (201-TCALM08) or email ettrial@cavionpharma.com.
 


 

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