Congenital Adrenal Hyperplasia
Neurocrine Biosciences completed a Phase II study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in adult patients with classic congenital adrenal hyperplasia (CAH). The final results from this open-label, multiple-dose, dose-escalation study were reported in June 2020.
Neurocrine Biosciences is currently enrolling patients in global registrational studies of crinecerfont in adult (18 years and older) and pediatric (2 years to 17 years) patients with classic CAH. For more information about these two Phase III clinical studies of crinecerfont, please visit www.CAHtalystStudy.com or clinicaltrials.gov for the adult study, and www.CAHtalystPediatricStudy.com or clinicaltrials.gov for the pediatric study.
Chorea Associated with Huntington Disease
Neurocrine Biosciences is conducting KINECT-HD, a multi-center randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy, safety and tolerability of valbenazine for the treatment of chorea in patients with Huntington disease (HD). HD is a hereditary progressive neurodegenerative disorder, in which many patients may experience chorea, a troublesome involuntary movement disorder. For more information on this Phase III study of valbenazine for the treatment of chorea associated with HD, please visit huntingtonstudygroup.org or clinicaltrials.gov.
Neurocrine Biosciences is conducting a Phase II STEAMBOAT™, double-blind study to assess the safety, tolerability, and pharmacokinetics of NBI-827104 in pediatric patients with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EE-CSWS). For more information about this Phase II study of NBI-827104, please visit https://stillwaterprogram.com/ or clinicaltrials.gov.
Luvadaxistat (NBI-1065844/TAK-831) is currently being evaluated in a Phase II INTERACT multi-center, randomized, double-blind, placebo-controlled, parallel study to evaluate efficacy, safety, tolerability, and pharmacokinetics of three dose levels as an adjunctive treatment of adult patients with negative symptoms of schizophrenia. For more information on this Phase II study of luvadaxistat, please visit clinicaltrials.gov.
Policy on expanded access to investigational medicines
Individuals interested in participating in clinical trials for Neurocrine Biosciences’ products may visit the “Pipeline” section of the website for information on ongoing clinical trials. At this time, Neurocrine Biosciences does not have an expanded access program that allows patients to have access to the Company’s investigational products prior to FDA approval. Neurocrine Biosciences will update this page as the Company grows and reassesses the approach to expanded access programs. If you have any questions, please contact firstname.lastname@example.org.