The RE-KINECT Study

Thank you for contacting Neurocrine Biosciences with your unsolicited Medical Information request regarding the RE-KINECT study.

RE-KINECT is a prospective real-world screening and registry study that aims to describe the presence and impact of involuntary movements (possible tardive dyskinesia [TD]) in up to 70 US outpatient psychiatric practices. Patients (≥18 years old) with ≥3 months lifetime exposure to antipsychotic(s) and ≥1 psychiatric disorder are eligible for screening, which involves a clinician observation of the presence and severity (“none,” “some” or “a lot”) of abnormal involuntary movements in 4 general body regions (head/face, neck/trunk, upper/lower limbs) and assessment of possible TD.

Recruitment for this study is ongoing. Interim data are available for 162 patients from 13 active sites broken into 2 study cohorts. Cohort one (patients without signs of uncontrollable or involuntary movement) included 111 (68.5%) patients. Cohort 2 (patients with clinician assessment of possible TD) consisted of 51 (31.5%) patients. Most patients had mood disorder as their primary psychiatric diagnosis (66.7% and 60.8% for Cohort 1 and Cohort 2, respectively).1

Uncontrollable movements (possible TD) were observed in all 4 regions. The highest presence of involuntary movement (possibly TD) was reported in the head/face region, with 19.6% of patients reporting severity as “a lot,” 39.2% “some” and 39.2% “none”. In this Cohort, 54.9% of patients had involuntary movement in 1 body region and 45.1% had an involuntary movement in 2 or more regions.1

For a complete description of these analyses, please see the attached data presentation from the 2017 Psych Congress annual meeting by Cutler et al.

This letter and the enclosed material are provided in response to your unsolicited medical information inquiry. Please feel free to contact Neurocrine Medical Information at (877) 641-3461 or medinfo@neurocrine.com if you would like to request additional information.

References:

  1. Cutler A et al. RE-KINECT: a prospective real-world dyskinesia screening study and registry in subjects taking antipsychotic agents: patient demographics. Poster presented at the 2017 Pysch Congress, New Orleans, LA.

Enclosures:

  1. Cutler A et al. RE-KINECT: a prospective real-world dyskinesia screening study and registry in subjects taking antipsychotic agents: patient demographics. Poster presented at the 2017 Pysch Congress, New Orleans, LA.

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