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-NL
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- 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-V™) diagnostic criteria for TS and, in the opinion of the investigator, patient, and caregiver/adult, 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 caregiver/adult 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 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.
i.Patient and caregiver/adult provided written informed consent/assent, depending on the child’s age, as appropriate, according to local regulations.
j.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 at baseline or are sterile. Definitions of sterile are given in Appendix E
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 the last dose of IMP. Further details are included in Appendix E.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before 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 first dose:
-within 3 months: depot neuroleptics, botulinum toxin, or tetrabenazine
-within 4 weeks: cannabidiol oil and valbenazine
-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 stimulant medications, including amphetamine, methylphenidate, and lisdexamfetamine, is allowed if primary use is for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), dosing has been stable for at least 2 weeks before screening, and no changes to dose or frequency are anticipated during the course of the study.
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, and no changes to dose or frequency are anticipated during the course of the study.
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 regardless of indication 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. If discontinuation of either medication is anticipated due to ineffectiveness, poor tolerability, or patient/caregiver preference, discontinuation should occur 4 or more weeks prior to the screening visit.
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 QT interval corrected for heart rate us
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