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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of a neurological condition like Parkinson's or Huntington's.

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I am not taking medications like digoxin, fluoxetine, valproic acid, or bupropion.

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I cannot swallow pills.

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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

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

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 • NCT04007991

16%

Headache

Insomnia

Somnolence

Fatigue

Nasopharyngitis

Restlessness

Anxiety

Nausea

Irritability

Depressed mood

Middle insomnia

Sleep disorder

Dizziness

Decreased appetite

Neck pain

Nasal congestion

Myalgia

Tic

Abdominal pain

Oropharyngeal pain

Fall

Muscle strain

Sunburn

Coronavirus infection

Depression

Vomiting

Diarrhea

Abdominal pain upper

Pyrexia

100%

80%

60%

40%

20%

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

0 / 8Eligibility criteria met