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Dopamine D1 Receptor Antagonist

Ecopipam for Tourette Syndrome (D1AMOND Trial)

Phase 2
Waitlist Available
Research Sponsored by Emalex Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, 9 and 12
Awards & highlights

Summary

This trial tested the safety of ecopipam tablets for children and adolescents with Tourette Syndrome. The medication aims to help manage their symptoms by affecting brain chemicals. Participants took the medication for an extended period with frequent check-ups. Ecopipam has shown promise in previous studies.

Eligible Conditions
  • Tourette Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 3, 6, 9 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 3, 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Electrocardiogram (ECG) Values Parameters: Aggregate PR Interval, Aggregate QRS Duration, Aggregate QT Interval, and Aggregate QTc Interval
Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells
Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells
+19 more
Secondary outcome measures
Change From Baseline in Clinical Global Impression of Tourette Syndrome of Severity (CGI-TS-S) at Months 1, 3, 6, 9, 12
Change From Baseline in Gilles de la Tourette Syndrome-Quality of Life Scale for Children and Adolescents (C&A-GTS-QOL) Total Score at Months 1, 3, 6, 9 and 12
Change From Baseline in the Yale Global Tic Severity Scale - Global Score (YGTSS-GS) at Months 1, 3, 6, 9 and 12
+3 more

Side effects data

From 2021 Phase 2 trial • 153 Patients • NCT04007991
16%
Headache
9%
Insomnia
8%
Somnolence
8%
Fatigue
7%
Nasopharyngitis
5%
Restlessness
5%
Anxiety
5%
Nausea
4%
Irritability
4%
Depressed mood
4%
Middle insomnia
4%
Sleep disorder
4%
Dizziness
3%
Nasal congestion
3%
Decreased appetite
3%
Abdominal pain
3%
Neck pain
3%
Oropharyngeal pain
3%
Tic
3%
Myalgia
3%
Fall
3%
Muscle strain
3%
Sunburn
1%
Vomiting
1%
Coronavirus infection
1%
Depression
1%
Diarrhea
1%
Abdominal pain upper
1%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ecopipam HCI 2 mg/kg/Day
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: EcopipamExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ecopipam
2019
Completed Phase 2
~500

Find a Location

Who is running the clinical trial?

Emalex Biosciences Inc.Lead Sponsor
14 Previous Clinical Trials
867 Total Patients Enrolled
3 Trials studying Tourette Syndrome
343 Patients Enrolled for Tourette Syndrome
~21 spots leftby Sep 2025
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