A clinical study in children and adolescents with Tourette Syndrome(TS) for assessment of efficacy of TEV-50717 (experimental drug).
- Conditions
- Tics associated with Tourette Syndrome(TS)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-002976-24-RO
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 158
a.Patient is 6 to 16 years of age, inclusive, at baseline.
b.Patient weighs at least 44 pounds (20 kg) at baseline.
c.Patient meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for TS and, in the opinion of the investigator, patient, and parent/legal guardian, the patient’s active tics are causing distress or impairment.
d.Patient has a TTS of 20 or higher on the YGTSS at screening and baseline.
e.Patient is able to swallow study medication whole.
f.Patient and parent/legal guardian are willing to adhere to the medication regimen and to comply with all study procedures.
g.Patient is in good general health, as indicated by medical and psychiatric history as well as physical and neurological examination.
h.In the investigator’s opinion, the patient and parent/legal guardian have the ability to understand the nature of the study and its procedures, and the patient is expected to complete the study as designed.
i.Patient and parent/legal guardian provided written informed consent according to local regulations (eg, the patient has provided written assent and/or co-consent, as appropriate).
j.Females who are postmenarchal or =12 years of age may be included only if they have a negative ß HCG test at baseline or are sterile.
k.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.
l.The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow up evaluation as specified in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
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
a.Patient has a neurologic disorder other than TS that could obscure the evaluation of tics.
b.The patient’s predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
c.Patient has clinically significant obsessive-compulsive disorder (OCD) at baseline that, in the opinion of the investigator, is the primary cause of impairment.
d.Patient has clinically significant depression at screening or baseline.
e.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
f.Patient has a history of a previous actual, interrupted, or aborted suicide attempt.
g.Patient has a first-degree relative who has completed suicide.
h.Patient has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
i.Patient has a DSM diagnosis based on the Mini International Neuropsychiatric Interview For Children and Adolescents Inventory at screening that, in the opinion of the investigator, makes the patient unsuitable for the study.
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 following specified exclusionary windows of screening:
-within 3 months: depot neuroleptics, botulinum toxin, or tetrabenazine
-within 21 days: reserpine
-within 14 days: neuroleptics (oral), typical and atypical antipsychotics (see Appendix H, Table 9), metoclopramide, levodopa, and dopamine agonists
Note: Use of benzodiazepines is allowed if 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 dosing has been stable for at least 4 weeks before screening.
Note: Use of guanfacine or clonidine is allowed if dosing has been stable for at least 4 weeks before screening.
l.Patient has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics.
m.Patient has a QTcF value >450 msec (males) or >460 msec (females), or >480 msec (with right bundle branch block) on a 12-lead electrocardiogram (ECG) at screening, or requires treatment with drugs known to prolong the QT interval (see Appendix H Table 10 for a complete list of prohibited QT-prolonging drugs).
n.Patient has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
o.Patient has evidence of hepatic impairment, as indicated by the following:
-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 >2 × ULN at screening
Note: Patients with Gilbert’s syndrome are eligible to participate if approved by the medical monitor.
Note: Patients with abnormalities in 2 or more of the following clinical laboratory parameters must be approved for enrollment by the medical monitor: AST, ALT, ALP, and total bilirubin.
p.Patient has evidence of clinically significant renal impairment, indicated by a serum creatinine >1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the efficacy of fixed doses of TEV 50717 to reduce motor and phonic tics associated with Tourette Syndrome;Secondary Objective: A secondary objective is to evaluate the safety and tolerability of TEV-50717;Primary end point(s): The primary efficacy endpoint is the change in the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) from baseline to week 8 between high-dose TEV 50717 treated patients and placebo-treated patients.;Timepoint(s) of evaluation of this end point: From baseline to Week 8
- Secondary Outcome Measures
Name Time Method