Purpose of the Kinect-DCP Study

The purpose of the Kinect-DCP Study is to determine if the study drug, called valbenazine, is safe to use and if it helps to improve involuntary movements that are difficult to control (dyskinesia) due to cerebral palsy (CP).

A photograph of a child and an adult baking.

Who May Qualify

Eligible participants must:

  • Be a child, adolescent, or adult 6 to 70 years of age
  • Have a confirmed diagnosis of dyskinesia (involuntary movements) due to CP
  • Not have involuntary movements due to conditions other than CP

There are additional eligibility criteria, which the study team will discuss with you.

Study Participation

Participation consists of the following periods:

  • Screening

    This period lasts up to 6 weeks with at least 1 visit. During this period, the study team performs assessments to determine eligibility for participation in the research study.

  • Double-blind treatment

    This period lasts 14 weeks with 7 visits. During this period, participants will take the study drug or placebo (looks just like the study drug but does not contain active ingredients) once daily, and the study team will check on their health. “Double-blind” means participants will be assigned at random (1:1 or like flipping a coin) to receive either the study drug or placebo, and neither the participant nor the study doctor will know which treatment they have been assigned to. However, in case of an emergency, the study doctor can quickly find out.

  • Washout period

    This washout period lasts 2 weeks and has 1 visit. During this period, participants will not receive the study drug or placebo.

  • Open-label treatment

    This period lasts 32 weeks with 6 visits. During this period, participants will take the study drug once daily, and the study team will check on their health. “Open-label” means all participants will receive the study drug, and know they are receiving the study drug. Following this period, participants will move to the washout-period follow-up visit OR the optional open-label extension (OLE).

  • Follow-up

    Following the open-label treatment period, for participants who choose not to be in the OLE, a washout period of 2 weeks will occur after the last dose of study drug. This follow-up visit will occur 2 weeks after a participant’s last dose, following washout period 2, with 1 visit to check on the participant’s health.

  • Optional open-label extension (OLE)

    Following the final treatment period, participants may choose to enter the optional OLE. This extension will last a minimum of 1 year, with visits every 12 weeks. If a participant does not opt into OLE, the follow-up visit will occur.

  • OLE follow-up visit

    If a participant chooses to participate in the OLE, they will have a follow-up visit 2 weeks after their final dose to check their health.

Throughout the research study, the study doctor may perform a number of tests and procedures, including but not limited to:

  • Recording your medical history
  • Conducting a physical exam
  • Measuring your vital signs
  • Conducting a pregnancy test (if applicable)
  • Blood and urine tests

About the Study Drug

The study drug, called valbenazine, is a once-daily oral medication that may be swallowed whole with water. It may also be opened, and the contents (granules) can be sprinkled onto and swallowed with soft food such as applesauce or pudding, or mixed in water and taken via gastrostomy tube. Researchers are comparing the study drug to placebo in the first treatment period, which lasts 14 weeks. The placebo looks just like the study drug but does not contain active ingredients. Placebos allow researchers to fully understand the effects of the study drug. In the second treatment period, which lasts 32 weeks, all participants will receive the study drug.

See who may qualify

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