Purpose of the Kinected 2 Study.
A medication called valbenazine (or INGREZZA®) was approved by the United States Food and Drug Administration
in April 2017 for the treatment of adults with tardive dyskinesia. Clinical research studies are being
conducted to gather more information on the safety, tolerability, and effectiveness of valbenazine.
The Kinected 2 Study is evaluating the safety, tolerability, and effectiveness of valbenazine while assessing
the effects of both taking and stopping investigational medication treatment on your tardive dyskinesia
Who may qualify.
Eligible participants must meet the following criteria, in addition to other criteria:
- Male or female between the ages of 18 and 85
- Diagnosed with schizophrenia, schizoaffective disorder, or mood disorder, and have medication-induced tardive dyskinesia for at least three months
- Willing and able to comply with the study instructions
There are additional eligibility requirements that the study doctor can explain to you.
Participation in the Kinected 2 Study lasts approximately 26 weeks and includes a screening period, a
treatment period, and a follow-up period. Participants will need to attend seven study visits throughout the
After you consent to participate in the study, you will need to attend a screening visit, where your study
doctor will perform tests and procedures to confirm your eligibility to take part in the study. The
screening portion of the study will last up to six weeks.
If you qualify based on the study criteria, you will be in this part of the study for 16 weeks. During
this time, you will receive the investigational medication, valbenazine, for eight weeks. At the end of
Week 8, you will be randomly assigned to continue receiving your current dose of valbenazine or switch to
receiving placebo for an additional eight weeks. The placebo looks like the investigational medication,
but it does not contain any active medicine.
A final checkup will be done four weeks after you stop taking the investigational medication (or placebo)
or when you leave the study.
See If You May Qualify