Jazz Pharmaceuticals plc announced that the first patient has been enrolled in a global Phase 2b clinical trial evaluating the safety and efficacy of suvecaltamide (also known as JZP385), a highly selective modulator of T-type calcium channels in development for the potential treatment of moderate to severe essential tremor (ET).1 The multicenter, double-blind, randomized, placebo-controlled trial will evaluate adults with moderate to severe ET treated with a once-daily oral capsule of suvecaltamide or placebo. ET is the most common movement disorder, yet a new pharmacotherapy has not been approved for the underlying cause of the disorder in more than 50 years.2,3,4
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“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,”1,4,5 said Mark A. Goldstein, M.D., 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.”
Investigators will conduct the trial across more than 50 trial sites in the United States (U.S.), United Kingdom (U.K.) and the European Union (EU). They will enroll 400 adults aged 18 to 80 diagnosed with ET as defined by the Consensus Statement on the Classification of Tremors from the Task Force on Tremor of the International Parkinson and Movement Disorder Society.6 Participants also must have moderate to severe disability associated with their tremor. In this double-blind, placebo-controlled trial, patients will receive a once-daily oral dose of 10, 20 or 30 milligrams of suvecaltamide or placebo for 12 weeks.