Clinical trial

A Multicenter, Open-Label, Extension Study Intended to Evaluate the Long-term Safety of Ecopipam Tablets in Children and Adolescent Subjects With Tourette's Syndrome

Name

EBS-101-OL-001

Description

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.

Trial arms

Trial start

2019-10-04

Estimated PCD

2022-11-11

Trial end

2022-11-11

Status

Completed

Phase

Early phase I

Treatment

Ecopipam

Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.

Arms:

Ecopipam

Size

124

Primary endpoint

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related)

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

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Erythrocytes

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Hematocrit

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Hemoglobin

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Leukocytes and Platelets

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Monocytes to Leukocytes Ratio Reported in Percentage of Cells

Baseline up to Month 12

Change From Baseline in Hematology Parameters: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells

Baseline up to Month 12

Change From Baseline in Serum Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Lactase Dehydrogenase

Baseline up to Month 12

Change From Baseline in Serum Chemistry Parameters: Albumin, Globulin and Protein

Baseline up to Month 12

Change From Baseline in Serum Chemistry Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglyceride and Urea Nitrogen

Baseline up to Month 12

Change From Baseline in Serum Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin

Baseline up to Month 12

Change From Baseline in Hemoglobin A1c (HbA1c)

Baseline up to Month 12

Change From Baseline in Vital Signs Parameter: Diastolic Blood Pressure and Systolic Blood Pressure

Baseline up to Month 12

Change From Baseline in Vital Signs Parameter: Pulse Rate

Baseline up to Month 12

Change From Baseline in Vital Signs Parameter: Body Mass Index [BMI]

Baseline up to Month 12

Change From Baseline in Vital Signs Parameter: Height

Baseline up to Month 12

Change From Baseline in Vital Signs Parameter: Weight

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

Baseline to Month 12

Number of Participants With Clinically Significant Abnormal Physical Examination Findings

Baseline up to Month 12

Eligibility criteria

Inclusion Criteria: * 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 reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation. Exclusion Criteria: * Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder). * Unstable medical illness or clinically significant lab abnormalities. * Risk of suicide. * Pregnant or lactating women. * Moderate to severe renal insufficiency. * Positive urine drug screen. * Certain medications that would lead to drug interactions.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open Label', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 124, 'type': 'ACTUAL'}}

Updated at

2024-02-01

1 organization

1 product

2 indications

Product

Ecopipam

Indication

Tourette Syndrome in Children

Indication

Tourette Syndrome

Organization

Emalex Biosciences