Children and Adolescent Subjects with Tourette’s Syndrome greater than or equal to 6 and less than or equal to 18 years of age
Conditions
Sponsors
Emalex Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major protocol deviation and must be who the Investigator feels would benefit from continued participation. 2) Adolescent females of childbearing potential who are sexually active must be using highly effective contraception (i.e., oral contraceptives, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasecetomized male partner) and agree to continue use of highly effective contraception for the duration of their participation in the study. They must also agree to use highly effective contraception for 30 days after their last dose of study drug. 3) Sexually active male subjects must use a highly effective method of contraception during the study and agree to continue the use of highly effective contraception for at least 30 days after the last dose of study drug. 4) Parents or legal guardians of subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects with a clinical presentation and/or history consistent with another neurologic condition that may have had accompanying abnormal movements (e.g., Huntington’s disease, Parkinson’s disease, Wilson’s disease, stroke, Restless Legs Syndrome). 2) History of schizophrenia, bipolar disorder, or other psychotic disorders. 3) Any unstable primary mood disorder (DSM-5 criteria) at time of Baseline. 4) Subjects who have unstable medical illness or clinically significant abnormalities on laboratory tests or ECG at Baseline as determined by the Principal Investigator. 5) Subjects who have moderate to severe renal insufficiency will be excluded given the large increase in systemic exposure of the N-desmethyl metabolite SCH 39166 and SCH 40853 observed in adults with moderate to severe renal impairment. 6) Subjects with a major depressive episode in the past 2 years. 7) Subjects with a history of attempted suicide. 8) A significant risk of committing suicide based on history, routine psychiatric status examination, Investigator’s judgment, or who had an answer of ‘‘yes’’ on any question other than 1–3 (currently or within the past 30 days) on the baseline/screening version of the C SSRS. 9) Subjects with a history of seizures (excluding febrile seizures that occurred >2 years prior to Baseline). 10) Subjects with a myocardial infarction within 6 months. 11) Female subjects who are currently pregnant or lactating or planning to become pregnant during the course of the study. 12) Subjects who have a need for medications which would have unfavorable interactions with ecopipam, e.g., dopamine antagonists or agonists [including bupropion], tetrabenazine, or monoamine oxidase inhibitors. 13) Subjects with current or recent (past 3 months) DSM-5 substance use disorder (with the exception of nicotine). 14) Subjects with positive urine drug screen for cocaine, amphetamine, methamphetamine, benzodiazepines, barbiturates, phencyclidine (PCP)or opiates at Baseline. Subjects with urine positive only for benzodiazepines will be exclusionary unless medically prescribed. 15) Subjects with a lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder. 16) Inability to swallow tablets. 17) Subjects with a known hypersensitivity to ecopipam or any of its excipients. 18) Any subject who in the opinion of the investigator is not a suitable candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in pediatric subjects (aged =6 to =18 years at Baseline) with Tourette’s Syndrome (TS) that were previously enrolled in the EBS-101-CL-001 study (Phase 2b) and completed the Phase 2b study without a major protocol deviation. ;Secondary Objective: The secondary objective is to evaluate the durability of effect of ecopipam in pediatric subjects (aged =6 to =18 years at Baseline) with TS.;Primary end point(s): Safety will be monitored throughout the study at all visits by repeated adverse event (AE) monitoring, vital signs, the Columbia-Suicide Severity Rating Scale (C-SSRS), the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Rating Scale (BARS), the Pediatric Anxiety Rating Scale (PARS) and Children's Depression Rating Scale-Revised (CDRS-R). In addition to these assessments, at Baseline, Months 1, 3, 6, 9 and 12 safety will also be monitored by clinical and laboratory evaluations and electrocardiogram (ECG) monitoring. At the Follow Up visit, AE monitoring, the C-SSRS, clinical and laboratory evaluations and vital signs will be assessed. Laboratory evaluations will include hematology, chemistry, urine values and HbA1c. A Follow Up phone call will be conducted 30 days after the last dose of study medication to assess AEs. Additional assessments (all visits except the follow up visit) will include the AIMS, the BARS, the CDRS-R and the PARS. C-SSRS will also be assessed (all visits including the Follow Up visit).;Timepoint(s) of evaluation of this end point: Adverse event (AE) monitoring, vital signs, the Columbia-Suicide Severity Rating Scale (C-SSRS), the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Rating Scale (BARS), the Pediatric Anxiety Rating Scale (PARS) and Children's Depression Rating Scale-Revised (CDRS-R) will be followed from Baseline to Month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Assessments: The YGTSS, CGI-TS-S, and C&A-GTS-QOL will be assessed at Baseline, Months 1, 3, 6, 9 and 12. The CGI-TS-I will be assessed at Months 1, 3, 6, 9 and 12. ;Timepoint(s) of evaluation of this end point: Efficacy Assessments: The YGTSS, CGI-TS-S, and C&A-GTS-QOL will be assessed at Baseline, Months 1, 3, 6, 9 and 12. The CGI-TS-I will be assessed at Months 1, 3, 6, 9 and 12. | — |
Countries
Canada, France, Germany, Poland, United States
Contacts
Public ContactClinical contact
Emalex Biosciences, Inc.
Outcome results
None listed