Suvecaltimide for Essential Tremors Clinical Trial Enrolls First Participant 

The first participant has been enrolled in the phase 2b clinical trial (NCT05122650) of suvecaltamide (JZP385; Jazz Pharmaceuticals, Philadelphia, PA) as potential treatment of moderate-to-severe essential tremor (ET). Trial investigators plan to enroll 400 adults, age 18 to 80 years, who are diagnosed with moderate-to-severe ET associated with moderate-to-severe disability. 

Participants will receive a once-daily oral dose of 10, 20, or 30 mg suvecaltimide or placebo for 12 weeks. Improvement in ET will be assessed with the combined Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) outcome score, which incorporates the Activities of Daily Living and Performance subscales. 

"Currently, patients with ET are treated with drugs that were not developed for this specific disorder. These therapies are often not well tolerated and do not fully control the frequent and involuntary tremors that patients with ET experience, leading them to discontinue treatment," said Mark A. Goldstein, MD, FAAN, medical director, JEM Research Institute and phase 2b trial investigator. "We look forward to evaluating suvecaltamide to increase our understanding of its potential to manage ET in adult patients."

"The International Essential Tremor Foundation is excited that a potential therapy to address a primary cause of ET is entering a clinical trial," said Patrick McCartney, executive director, International Essential Tremor Foundation. "The lack of a targeted treatment for patients with ET means that they must rely on their perseverance to grapple with the challenges they experience in their daily lives due to the disorder."

Suvecaltimide is a highly selective T-type calcium channels modulator. If it proves efficacious and is eventually approved, it will be the first new medication for ET in over 50 years.