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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

D1AMOND Trial Summary

This trial is testing the safety of a drug called ecopipam for treating children and teens with Tourette Syndrome.

Eligible Conditions
  • Tourette Syndrome

D1AMOND Trial Eligibility Criteria

Inclusion Criteria

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

D1AMOND Trial 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%
Fatigue
8%
Somnolence
7%
Nasopharyngitis
5%
Nausea
5%
Anxiety
5%
Restlessness
4%
Irritability
4%
Dizziness
4%
Middle insomnia
4%
Depressed mood
4%
Sleep disorder
3%
Abdominal pain
3%
Muscle strain
3%
Sunburn
3%
Oropharyngeal pain
3%
Fall
3%
Myalgia
3%
Neck pain
3%
Nasal congestion
3%
Tic
3%
Decreased appetite
1%
Coronavirus infection
1%
Vomiting
1%
Abdominal pain upper
1%
Diarrhea
1%
Pyrexia
1%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ecopipam HCI 2 mg/kg/Day
Placebo

D1AMOND 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
~460

Find a Location

Who is running the clinical trial?

Emalex Biosciences Inc.Lead Sponsor
10 Previous Clinical Trials
768 Total Patients Enrolled
2 Trials studying Tourette Syndrome
303 Patients Enrolled for Tourette Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
Indiana
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
UCLA
CHU Sainte-Justine
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have this problem since childhood and my father also has this problem. He sometimes stops while speaking and repeats a word again and again. Along with this, we also have anxiety.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
2019. "Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04114539.
~23 spots leftby Apr 2025
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