Trial · NCT04114539
Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
NCT04114539, Phase 2, Completed, Emalex Biosciences Inc.; results first posted 2023-12-01
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension. Trials, record NCT04114539. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04114539
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
- NCT number
- NCT04114539
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Emalex Biosciences Inc.
- Conditions
- Tourette Syndrome in Children, Tourette Syndrome in Adolescence
- Interventions
- Ecopipam
- First posted
- 2019-10-03
- Last updated
- 2024-02-01
- Results first posted
- 2023-12-01
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | An AE was any untoward medical condition that occurs in a participant while participating in this clinical study. It can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. The relationship of the study drug in causing or contributing to the AE whether unrelated, possibly related, or probably related was decided by investigator medical judgment. |
| Primary | Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | Basophils/Leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in basophils to leukocytes ratio is reported in terms of percentage of cells. |
| Primary | Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | Eosinophils/Leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in eosinophils to leukocytes ratio is reported in terms of percentage of cells. |
| Primary | Change From Baseline in Hematology Parameters: Erythrocytes | Baseline up to Month 12 | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter erythrocytes was reported. |
| Primary | Change From Baseline in Hematology Parameters: Hematocrit | Baseline up to Month 12 | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter hematocrit was reported. |
| Primary | Change From Baseline in Hematology Parameters: Hemoglobin | Baseline up to Month 12 | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter hemoglobin was reported. |
| Primary | Change From Baseline in Hematology Parameters: Leukocytes and Platelets | Baseline up to Month 12 | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameters (Leukocytes and Platelets) expressed in 10\^9 cells per liter were reported. |
| Primary | Change From Baseline in Hematology Parameters: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | Lymphocytes/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in lymphocytes to leukocytes ratio is reported in terms of percentage of cells. |
| Primary | Change From Baseline in Hematology Parameters: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | Monocytes/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in monocytes to leukocytes ratio is reported in terms of percentage of cells. |
| Primary | Change From Baseline in Hematology Parameters: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | Neutrophils/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in neutrophils to leukocytes ratio is reported in terms of percentage of cells. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Erythrocytes | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | 10^12 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hematocrit | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | liter of cells per liter of blood (L/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hemoglobin | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | millimoles per liter (mmoL/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Leukocytes and Platelets | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | 10^9 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with any AEs | 84 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with SAEs | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with unrelated AEs | 44 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with possibly related AEs | 27 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with probably related AEs | 13 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with unrelated SAEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with possibly related SAEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | Ecopipam HCI 2 mg/kg/Day | Participants with probably related SAEs | 0 | Participants | |
| Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Ecopipam HCI 2 mg/kg/Day | -0.1 | Standard Deviation 0.91 | percentage of cells | |
| Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Ecopipam HCI 2 mg/kg/Day | 0.1 | Standard Deviation 1.52 | percentage of cells |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ecopipam HCl 2 mg/kg/Day | 124 | |
| Overall Study | Safety Set (Treated) | Ecopipam HCl 2 mg/kg/Day | 121 | |
| Overall Study | Modified Intention-to-Treat Set | Ecopipam HCl 2 mg/kg/Day | 121 | |
| Overall Study | COMPLETED | Ecopipam HCl 2 mg/kg/Day | 80 | |
| Overall Study | NOT COMPLETED | Ecopipam HCl 2 mg/kg/Day | 44 |
Source ClinicalTrials.gov
Adverse events119
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tourette's disorder | Congenital, familial and genetic disorders | Ecopipam HCI 2 mg/kg/Day | 1 | 121 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Ecopipam HCI 2 mg/kg/Day | 2 | 121 | 2 |
| other | Vision blurred | Eye disorders | Ecopipam HCI 2 mg/kg/Day | 1 | 121 | 1 |
| other | Visual impairment | Eye disorders | Ecopipam HCI 2 mg/kg/Day | 1 | 121 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Ecopipam HCI 2 mg/kg/Day | 9 | 121 | 10 |
| other | Nausea | Gastrointestinal disorders | Ecopipam HCI 2 mg/kg/Day | 6 | 121 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | Ecopipam HCI 2 mg/kg/Day | 5 | 121 | 5 |
| other | Vomiting | Gastrointestinal disorders | Ecopipam HCI 2 mg/kg/Day | 5 | 121 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Ecopipam HCI 2 mg/kg/Day | 4 | 121 | 7 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Ecopipam HCI 2 mg/kg/Day | 3 | 121 | 3 |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ecopipam HCI 2 mg/kg/Day | 0 | 121 |
| Total, other adverse events | Ecopipam HCI 2 mg/kg/Day | 84 | 121 |
| Total, serious adverse events | Ecopipam HCI 2 mg/kg/Day | 2 | 121 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04114539/registered?page=2