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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to month 24
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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

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
~500

Find a Location

Who is running the clinical trial?

Emalex Biosciences Inc.Lead Sponsor
13 Previous Clinical Trials
807 Total Patients Enrolled
3 Trials studying Tourette Syndrome
317 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.

What is the upper limit on enrollment in this clinical trial?

"Affirmative. Documentation accessible on clinicaltrials.gov shows that this medical investigation, first published August 16th 2023, is currently enrolling participants. The trial requires 150 people to be recruited from a single research site."

Answered by AI

Does the Food and Drug Administration endorse a 1.8 mg/kg/day dosage of Ecopipam?

"Due to the existing efficacy and safety data, our Power team assigned Ecopipam 1.8 mg/kg/day a rating of 3 on the scale from 1-3. This denotes that it is in its third phase of clinical trial stages."

Answered by AI

Are there still slots available for participants in this medical research project?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively recruiting members and was first posted on August 16th 2023 with the most recent update being made on August 28th 2023. 150 volunteers are needed at a single site for enrolment purposes."

Answered by AI

Who else is applying?

What site did they apply to?
Access Clinical Trials, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder
2023. "A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06021522.
All > Omaha > Tourette Syndrome
~64 spots leftby Nov 2024
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