PHASE 3 Study Drug May Help Manage Tardive Dyskinesia

The Segal Institute is excited to participate in an important research study of a phase III drug that may help manage Tardive Dyskinesia (TD).  By participating in this research, we may help bring much-needed new treatments to our patients living with TD.  Made up of nine sites throughout South Florida and South Carolina, the Segal Institute and its dedicated team play an integral role in developing new and life-changing treatments.  By participating in this TD trial, Segal is renewing its commitment to supporting patients with a wide variety of diagnoses.

Neurocrine Biosciences, a San Diego-based biopharmaceutical company focusing on therapies for neurological and endocrine diseases and disorders, is developing a drug that aims to manage a number of symptoms associated with Tardive Dyskinesia and other involuntary movement disorders.  Currently undergoing Phase III of the study process, this drug (NBI-98854)’s selective nature may also reduce the likelihood of undesirable side effects while improving TD symptoms.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the muscles of the face, trunk or limbs.  These movements may include, but are not limited to: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or involuntary movements of the limbs. These symptoms may present after months or years of treatment with typical and atypical antipsychotics for schizophrenia, bipolar, and major depressive disorder (MDD). Currently there is no treatment approved for these rarely reversible symptoms.

NBI-98854, a potent and highly selective VMAT2 inhibitor, has been shown to be effective in regulating the levels of dopamine release during nerve communication, while also minimizing the impact on the other monoamines.

In addition to effectively treating symptoms of TD, Neurocrine Biosciences believes that NBI-98854 may also be effective in the management of other hyperkinetic movement disorders characterized by involuntary bodily movements such as Tourette syndrome, tardive dystonia, and Huntington’s disease. Also, because the drug modulates dopamine pathways, treatment may also be useful for patients suffering from schizophrenia – a population at risk for tardive dyskinesia.

This study will be conducted at the following three locations: Dr. Segal’s site in North Miami, Florida, Dr. Kakar’s site in Lauderhill, FL, and Dr. Cifuentes’ site in Charleston, SC.

If you or someone you know might be experiencing symptoms of TD and would like to learn more about current research opportunities, please contact our team. Segal Institute conducts studies within psychiatry, neurology, women’s health, and addiction; we are committed to finding treatments and innovative new medications to improve patient well-being.  Clinical trials can provide access to new or experimental treatments like NBI-98854 that otherwise aren’t available to the public.

For more information about Segal Trials and to learn how you can participate in a clinical research study, contact: Maryan Negron at 305-722-1981 or send an e-mail to [email protected]



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