A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents

Inclusion Criteria:

• Participant is 6 through 18 years of age (inclusive) at baseline.
• Participant weighs at least 26 pounds (12 kg) at baseline.
• Participant has had CP symptoms since infancy (≤2 years)
• Choreiform is the prevalent movement disorder as assessed by the EAB at screening.
• Participant has a diagnosis of DCP
• Participant is able to swallow study medication whole.
• Females who are postmenarchal or ≥12 years of age whose male partners are potentiallyfertile (ie, no vasectomy) must use highly effective birth control methods for theduration of the study
• Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• Participant has a predominant movement disorder other than dyskinesia.
• Participant's predominant motor symptoms are dystonic.
• Participant's predominant motor symptoms are spastic.
• Participant has choreiform movement disorder that has not been consistent throughoutthe life of the participant.
• Participant has clinically significant depression at screening or baseline.
• Note: Participants receiving antidepressant therapy may be enrolled if on a stabledose for at least 6 weeks before screening.
• Participant has a history of suicidal intent or related behaviors within 2 years ofscreening:
• Previous intent to act on suicidal ideation with a specific plan, irrespective oflevel of ambivalence, at the time of suicidal thought
• Previous suicidal preparatory acts or behavior
• Participant has a history of a previous actual, interrupted, or aborted suicideattempt.
• Participant has a first-degree relative who has completed suicide.
• Participant has received treatment with stem cells, deep brain stimulation,transmagnetic stimulation, or transcranial direct current stimulation for treatment ofabnormal movements or CP within 6 months of the screening visit, or the participant isnot in a stable clinical condition.
• Participant has recent surgical procedure or is anticipated to have a surgicalprocedure during the study that, in the opinion of the investigator, makes theParticipant unsuitable for the study.
• Participant has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) at screening or baseline that, in the opinion of the investigator,could jeopardize or would compromise the Participant's ability to participate in thisstudy.
• Participant has a known allergy to any of the components of the investigationalmedicinal product (IMP).
• Participant is pregnant or breastfeeding.
• Participant has a history of or acknowledges alcohol or substance abuse in the 12months before screening
• Participants with a history of torsade de pointes, congenital long QT syndrome,bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
• Additional criteria apply, please contact the investigator for more information