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Ecopipam for Tourette Syndrome
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
Participants must be aged between 6 to 18 years
Participant must have TD based on Diagnostic and Statistical Manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD
Must not have
Participants with ongoing or past history of neurological condition (e.g., Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless Legs Syndrome)
Certain medications that would have unfavorable drug interactions with ecopipam, e.g., digoxin, fluoxetine, valproic acid, bupropion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to month 24
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial studies the long-term safety and tolerability of ecopipam tablets to treat Tourette's Syndrome (TS) in kids, teens and adults.
Who is the study for?
This trial is for children (6+), adolescents, and adults with Tourette's Syndrome who have shown improvement on ecopipam. Participants must not have certain neurological conditions, unstable mood disorders, severe kidney or liver issues, or a recent history of substance abuse. Pregnant women and those unable to swallow tablets are excluded.
What is being tested?
The study tests the long-term safety of ecopipam tablets in treating Tourette's Syndrome across various age groups. It aims to understand how well patients tolerate this medication over an extended period.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions to ecopipam throughout the trial to assess its long-term safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 18 years old.
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I have been diagnosed with Tardive Dyskinesia according to DSM-5 criteria.
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I have Tourette's with both motor and vocal tics that disrupt my daily life.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of a neurological condition like Parkinson's or Huntington's.
Select...
I am not taking medications like digoxin, fluoxetine, valproic acid, or bupropion.
Select...
I cannot swallow pills.
Select...
I have had a heart attack in the last 6 months.
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I am taking medication for tics and/or for depression or anxiety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to month 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Side effects data
From 2021 Phase 2 trial • 153 Patients • NCT0400799116%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ecopipam 1.8 mg/kg/dayExperimental Treatment1 Intervention
Ecopipam tablets will be administered orally (PO) once daily in the evening without regard to meals at concentrations 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 milligrams (mg) containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively in 4-week titration phase to achieve a target dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam HCl). Participants will be evaluated for safety at each baseline visit and at all treatment visits up to 24 months and at follow up visits at 7 and 14 days after last dose of ecopipam.
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
870 Total Patients Enrolled
4 Trials studying Tourette Syndrome
513 Patients Enrolled for Tourette Syndrome