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Dopamine D1 Receptor Antagonist

Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12

Summary

This trial is testing if ecopipam tablets help treat Tourette's Syndrome in children and adolescents.

Eligible Conditions
  • Tourette Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12
Secondary study objectives
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12

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%
Oropharyngeal pain
3%
Myalgia
3%
Decreased appetite
3%
Neck pain
3%
Tic
3%
Abdominal pain
3%
Nasal congestion
3%
Fall
3%
Muscle strain
3%
Sunburn
1%
Abdominal pain upper
1%
Depression
1%
Vomiting
1%
Coronavirus infection
1%
Diarrhea
1%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ecopipam HCI 2 mg/kg/Day
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ecopipam HCI 2 mg/kg/dayExperimental Treatment1 Intervention
Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings
Group II: PlaceboPlacebo Group2 Interventions
Matching Placebo tablets taken orally in the evening
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ecopipam
2019
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

Emalex Biosciences Inc.Lead Sponsor
15 Previous Clinical Trials
867 Total Patients Enrolled
4 Trials studying Tourette Syndrome
510 Patients Enrolled for Tourette Syndrome
~24 spots leftby Jan 2026
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