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.
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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