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Dopamine D1 Receptor Antagonist

Ecopipam for Tourette Syndrome (D1AMOND Trial)

Phase 3
Recruiting
Research Sponsored by Emalex Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 6 years of age
≥ 18 kg (~ 40 lbs.)
Timeline
Screening 14 weeks
Treatment 24 weeks
Follow Up 30 days
Awards & highlights

D1AMOND Trial Summary

This trial studies how safe and effective ecopipam is for treating Tourette's Disorder in kids, teens and adults.

Who is the study for?
This trial is for children, adolescents, and adults with Tourette's Disorder who weigh at least 40 lbs and have a significant number of tics. Participants must not be on tic medications for two weeks before the study starts and should use effective contraception if sexually active.Check my eligibility
What is being tested?
The study tests ecopipam tablets to see if they help maintain control over tics in people with Tourette's. It starts with an open phase where everyone gets the drug, followed by a random phase where half get ecopipam and half get a placebo without knowing which one they're taking.See study design
What are the potential side effects?
Possible side effects of ecopipam may include difficulty sleeping, restlessness, fatigue, changes in mood or behavior. Since it's being tested, there might be other unknown side effects that could emerge during the trial.

D1AMOND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 6 years old or older.
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I weigh at least 40 pounds.
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I have Tourette's with both motor and vocal tics that disrupt my daily life.
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I haven't taken medication for motor or vocal tics in the last 14 days.
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I am using effective birth control during and for 30 days after the study.

D1AMOND Trial Timeline

Screening ~ 14 weeks
Treatment ~ 24 weeks
Follow Up ~30 days
This trial's timeline: 14 weeks for screening, 24 weeks for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Yale Global Tic Severity Scale (YGTSS)

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)Experimental Treatment1 Intervention
Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.
Group II: Placebo during R/WD PhasePlacebo Group1 Intervention
Matching Placebo tablets during R/WD period taken orally in the evening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ecopipam Hydrochloride
2023
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Emalex Biosciences Inc.Lead Sponsor
13 Previous Clinical Trials
761 Total Patients Enrolled
4 Trials studying Tourette Syndrome
467 Patients Enrolled for Tourette Syndrome

Media Library

Ecopipam Hydrochloride (Dopamine D1 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05615220 — Phase 3
Tourette Syndrome Research Study Groups: 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl), Placebo during R/WD Phase
Tourette Syndrome Clinical Trial 2023: Ecopipam Hydrochloride Highlights & Side Effects. Trial Name: NCT05615220 — Phase 3
Ecopipam Hydrochloride (Dopamine D1 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05615220 — Phase 3

Frequently Asked Questions

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

Can people with the disease join this clinical trial right now?

"According to the information available on clinicaltrials.gov, this trial is not currently looking for candidates. The study was initially posted on 12/1/2022 and was most recently updated on 11/7/2022. While this particular clinical trial may have completed recruitment, there are 33 other studies actively looking for participants at this time."

Answered by AI

Do patients experience any side effects from taking 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)?

"1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) is considered safe by our team because it has received a score of 3. A phase 3 trial collects data to support efficacy and safety, so this medication has gone through multiple rounds of testing."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
The University of Chicago Hospitals
Michigan Clinical Research Institute PC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

What all does it entail?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I believe I have the syndrome and can help this study. Because I think I have an undiagnosed form of this condition.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
2023. "Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05615220.
All > Tourette Syndrome
~53 spots leftby Dec 2024
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