This study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.
Age range
6 Years – 18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related)
Timeframe: From start of study drug administration until 30 days after last dose (Up to Month 13)
Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Erythrocytes
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Hematocrit
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Hemoglobin
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Monocytes to Leukocytes Ratio Reported in Percentage of Cells
Timeframe: Baseline up to Month 12
Change From Baseline in Hematology Parameters: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells
Timeframe: Baseline up to Month 12
Change From Baseline in Serum Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Lactase Dehydrogenase
Timeframe: Baseline up to Month 12
Change From Baseline in Serum Chemistry Parameters: Albumin, Globulin and Protein
Timeframe: Baseline up to Month 12
Change From Baseline in Serum Chemistry Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglyceride and Urea Nitrogen
Timeframe: Baseline up to Month 12
Change From Baseline in Serum Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin
Timeframe: Baseline up to Month 12
Change From Baseline in Hemoglobin A1c (HbA1c)
Timeframe: Baseline up to Month 12
Change From Baseline in Vital Signs Parameter: Diastolic Blood Pressure and Systolic Blood Pressure
Timeframe: Baseline up to Month 12
Change From Baseline in Vital Signs Parameter: Pulse Rate
Timeframe: Baseline up to Month 12
Change From Baseline in Vital Signs Parameter: Body Mass Index [BMI]
Timeframe: Baseline up to Month 12
Change From Baseline in Vital Signs Parameter: Height
Timeframe: Baseline up to Month 12
Change From Baseline in Vital Signs Parameter: Weight
Timeframe: Baseline up to Month 12
Change From Baseline in Electrocardiogram (ECG) Values Parameters: Aggregate PR Interval, Aggregate QRS Duration, Aggregate QT Interval, and Aggregate QTc Interval
Timeframe: Baseline to Month 12
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Timeframe: Baseline up to Month 12