A clinical study in children and adolescents with Tourette Syndrome to investigate the safety of TEV-50717 (experimental drug).

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 227

Inclusion Criteria

a. Patient is younger than 18 years of age on day 1.
b. Patient weighs at least 44 pounds (20 kg) on day 1.
c. Patient is able to swallow IMP whole.
d. Patient and caregiver/adult are willing to adhere to IMP regimen and comply with all
study procedures.
e. Patient is in good general health, as indicated by medical and psychiatric history as
well as physical and neurological examination.
f. In the investigator’s opinion, the patient and caregiver/adult have the ability to
understand the nature of the study and its procedures, and the patient is expected to
complete the study as designed.
g. Patient and caregiver/adult provide written informed consent/assent, depending on the
child’s age, as appropriate, according to local regulations.
h. Females who are postmenarchal or =12 years of age may be included only if they
have a negative beta-human chorionic gonadotropin (ß-HCG) test on day 1 or are
sterile. Definitions of sterile are given in Appendix L.
i. Females who are postmenarchal or =12 years of age whose male partners are
potentially fertile (ie, no vasectomy) must use highly effective birth control methods
for the duration of the study (ie, starting at screening) and for 30 days or 5 half-lives,
whichever is longer after last dose of IMP. Further details are included in
Appendix L.
Are the trial subjects under 18? yes
Number of subjects for this age range: 227
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

a. Patient is 18 years of age or older.
b. Patient has a neurologic disorder other than TS that could obscure
the evaluation of tics.
c. The patient's predominant movement disorder is stereotypy
(coordinated movements that repeat continually and identically)
associated with autism spectrum disorder.
d. Patient has a confirmed diagnosis of bipolar disorder, schizophrenia,
or another psychotic disorder.
e. Patient has clinically significant depression at screening or day 1.
f. Patient has a history of suicidal intent or related behaviors within 2
years of screening:
? previous intent to act on suicidal ideation with a specific plan,
irrespective of level of ambivalence, at the time of suicidal thought
? previous suicidal preparatory acts or behavior
g. Patient has a history of a previous actual, interrupted, or aborted
suicide attempt.
h. Patient has a first-degree relative who has completed suicide.
i. Patient has clinically significant obsessive-compulsive disorder (OCD)
on day 1 that, in the opinion of the investigator, is the primary cause of
impairment.
j. Patient has received comprehensive behavioral intervention for tics
for TS or cognitive behavioral therapy for OCD within 4 weeks of
screening.
k. Patient has received any of the following concomitant medications
for tics within the specified exclusionary windows of screening prior to
dosing for washout:
? within 3 months: depot neuroleptics, botulinum toxin, or
tetrabenazine
? within 4 weeks: cannabidiol oil or valbenazine
? within 21 days: reserpine
? within 14 days: neuroleptics (oral), typical and atypical
antipsychotics (see Appendix A, Table 7), metoclopramide, levodopa,
and dopamine agonists
Note: Use of stimulant medications, including amphetamine,
methylphenidate, and lisdexamfetamine, is allowed if primary use is for
the treatment of ADHD, dosing has been stable for at least 2 weeks
before screening.
Note: Use of atomoxetine is allowed if the primary use is for the
treatment of ADHD, dosing has been stable for at least 4 weeks before
screening.
Note: Use of benzodiazepines is allowed if the primary use is not for tics,
and dosing has been stable for at least 4 weeks before screening.
Note: Use of topiramate (up to 200 mg/day) is allowed if the dosing has
been stable for at least 4 weeks before screening.
Note: Use of guanfacine or clonidine is allowed regardless of indication
(ie, if prescribed for tics or Tourette syndrome) if the dosing has been
stable for at least 4 weeks before screening and no changes to dose or
frequency are anticipated during the course of the study.
l. Patient has an unstable or serious medical illness at screening or day 1.
m. Patient has a QT interval corrected for heart rate using Fridericia's
formula (QTcF) interval value >450 msec (males) or >460 msec
(females), or >480 msec (with right bundle branch block) on 12-lead
ECG at screening. Patient requires treatment with drugs known to
prolong the QT interval (see Appendix A Table 8 for a complete list ofprohibited QT-prolonging drugs).
n. Patients with a history of torsade de pointes, congenital long QT
syndrome, bradyarrhythmias, or uncompensated heart failure.
o. Patient has evidence of hepatic impairment, as indicated by:
? aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
>2.5 × the upper limit of the normal range (ULN) at screening
? alkaline phosphatase (ALP) or total bilirubin (Tbil) >2 × ULN at
screening
Note: Patients with Gilbert's Syndrome are eligible to participate

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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