Trial · NCT04007991

Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents

NCT04007991, Phase 2, Completed, Emalex Biosciences Inc.; results first posted 2023-10-04

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents. Trials, record NCT04007991. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04007991

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
NCT number: NCT04007991
Status: Completed
Phases: Phase 2
Enrollment: 153 participants, actual
Lead sponsor: Emalex Biosciences Inc.
Conditions: Tourette Syndrome
Interventions: Ecopipam, Placebo
First posted: 2019-07-05
Last updated: 2023-10-04
Results first posted: 2023-10-04

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12	Baseline, Week 12	The YGTSS was a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0=none to 5=severe for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms. A negative change from baseline indicates improvement.
Secondary	Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12	Baseline, Week 12	Clinical Global Impression (CGI) scale was used to assess overall severity on a 7-point Likert scale consisted of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The CGI severity scale ranges from 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill subject. 1 = "normal, not ill at all" to 7 = "extremely ill." A negative change indicates improvement in the condition.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12	Baseline, Week 12	The mITT set included all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline scoring of the YGTSS.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12	Baseline, Week 12	The mITT set included all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline scoring of the YGTSS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12	Ecopipam HCI 2 mg/kg/Day	-9.87	Standard Error 1.062	score on a scale
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12	Placebo	-6.42	Standard Error 1.006	score on a scale
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12	Ecopipam HCI 2 mg/kg/Day	-0.91	Standard Error 0.141	score on a scale
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12	Placebo	-0.53	Standard Error 0.130	score on a scale

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ecopipam HCI 2 mg/kg/Day	76
Overall Study	STARTED	Placebo	77
Overall Study	Safety Set	Ecopipam HCI 2 mg/kg/Day	76
Overall Study	Safety Set	Placebo	77
Overall Study	The Modified Intention-to-Treat Set	Ecopipam HCI 2 mg/kg/Day	74
Overall Study	The Modified Intention-to-Treat Set	Placebo	75
Overall Study	COMPLETED	Ecopipam HCI 2 mg/kg/Day	66
Overall Study	COMPLETED	Placebo	71
Overall Study	NOT COMPLETED	Ecopipam HCI 2 mg/kg/Day	10
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events68

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
other	Contusion	Injury, poisoning and procedural complications	Ecopipam HCI 2 mg/kg/Day	0	76
other	Contusion	Injury, poisoning and procedural complications	Placebo	3	77
other	Fall	Injury, poisoning and procedural complications	Ecopipam HCI 2 mg/kg/Day	2	76
other	Fall	Injury, poisoning and procedural complications	Placebo	0	77
other	Muscle strain	Injury, poisoning and procedural complications	Ecopipam HCI 2 mg/kg/Day	2	76
other	Muscle strain	Injury, poisoning and procedural complications	Placebo	0	77
other	Sunburn	Injury, poisoning and procedural complications	Ecopipam HCI 2 mg/kg/Day	2	76
other	Sunburn	Injury, poisoning and procedural complications	Placebo	1	77
other	Headache	Nervous system disorders	Ecopipam HCI 2 mg/kg/Day	12	76
other	Headache	Nervous system disorders	Placebo	7	77

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ecopipam HCI 2 mg/kg/Day	0	76
Total, all-cause mortality	Placebo	0	77
Total, other adverse events	Ecopipam HCI 2 mg/kg/Day	47	76
Total, other adverse events	Placebo	38	77
Total, serious adverse events	Ecopipam HCI 2 mg/kg/Day	2	76
Total, serious adverse events	Placebo	1	77

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ecopipam HCI 2 mg/kg/Day vs Placebo: deaths from any cause	Trial comparisons
Ecopipam HCI 2 mg/kg/Day vs Placebo: serious adverse events	Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04007991

GET https://conductscience.org/api/trials/v1/NCT04007991/events?page=2

API reference For AI assistants