JOURNEY STUDY - "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia” NBI-98854-ATS3019

The purpose of this Journey Study is to find out how safe the study drug, called valbenazine, is, how well the body handles taking it (tolerability), and how well it works as an add-on therapy in study participants with schizophrenia who did not respond well enough to antipsychotic therapy. This study aims to find out how well the study drug works compared to a placebo as an add-on therapy in participants who still experience symptoms. Placebos are made of a substance that looks just like the study drug being tested, but they contain no active ingredients. The first dose of study treatment will occur when subjects are enrolled (up to 4 weeks after the screening visit), and the follow-up period will be approximately 2 weeks following a participant’s final dose.

Study Length:

The study will last for approximately 16 weeks (4-week screening period, 10-week study treatment period, 2-week washout/follow-up period) with 7 study visits.

Disorder/Condition:

Schizophrenia

Inclusion Criteria:

Be male or female aged ≥ 18 years old
Be diagnosed with schizophrenia for at least 1 year prior to the start of the research study
Be receiving a daily dose of antipsychotic therapy (other than clozapine)
Have a history of not responding well to antipsychotic treatment

Study Title (brief):

JOURNEY STUDY: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia

Study Description (brief):

The purpose of this Journey Study is to find out how safe the study drug, called valbenazine, is, how well the body handles taking it (tolerability), and how well it works as an add-on therapy in study participants with schizophrenia who did not respond well enough to antipsychotic therapy. This study aims to find out how well the study drug works compared to a placebo as an add-on therapy in participants who still experience symptoms. Placebos are made of a substance that looks just like the study drug being tested, but they contain no active ingredients. The first dose of study treatment will occur when subjects are enrolled (up to 4 weeks after the screening visit), and the follow-up period will be approximately 2 weeks following a participant’s final dose.

Study Contact:

For more information about this study, please contact Malathi Perugula, research coordinator, at 212-961-8992 or Malathi.Perugula@omh.ny.gov [2].

Study Location:

Manhattan Psychiatric Center’s 125th Street Clinic, 163 West 125th Street, 11th and 12th Floors, NY, NY 10027