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A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

Primary Purpose

Tourette Syndrome

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ecopipam
Sponsored by
Emalex Biosciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Ecopipam, Neurodevelopmental Disorders, Mental Disorders, Central Nervous System Depressants, Neurodegenerative Diseases, Movement Disorders, Tic Disorders, Nervous System Diseases, Central Nervous System Diseases, Brain Diseases

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >=6 to >=18 years of age. Participants enrolling from the study EBS-101-TD-301; completed all visits through Week 24 and days 7 and 14 safety follow-up, met relapse criteria during the double-blind randomized (R/WD) period after completing the 301 end of trial (ET) visit, the 7 day and 14 day safety follow up visits, but not before 24 weeks following the 301 baseline visit or participants who met relapse criteria will be eligible after completing early termination visit, Day 7 and Day 14 follow up visits. Participants who completed the studies EBS-101-OL-001 or PSY302A. The enrolling participant must have had clinical benefit from ecopipam and would benefit from continued participation. Effective contraception during the study and 30 days after last study dose for sexually active participants <18 years of age participants parent/legal guardian must sign a written informed consent and participant must sign a written informed assent. Participant must have TD based on Diagnostic and Statistical Manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD. TD diagnosis and both motor and vocal tics that cause impairment with normal routines Exclusion Criteria: The participants who discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent, non-compliant or withdrawn by the discretion of either the site investigator or the sponsor. Participants with ongoing or past history of neurological condition (example [e.g.], Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless Legs Syndrome). Any unstable mood disorder (DSM-5-TR criteria), mental illness or clinically significant lab abnormalities, moderate to severe renal or hepatic impairment, a PHQ-9 score >=10 at screening and history of neuroleptic malignant syndrome at the time of screening or baseline. Participants who completed the studies EBS-101-OL-001 or PSY-302A and who had previous exposure to ecopipam and oral neuroleptics within 4 weeks and depot neuroleptics within 3 months prior to screening, 6 months prior to Baseline. Participants receiving any other medication to treat motor or vocal tics and anti-depressant or anti-anxiety medications. Risk of suicide as per PI judgement Pregnant or lactating women Certain medications that would have unfavorable drug interactions with ecopipam, e.g., digoxin, fluoxetine, valproic acid, bupropion. Current or recent (past 3 months) DSM-5-TR substance use disorder (with the exception of nicotine). Recent behavioral therapy Positive urine drug screen for cocaine, amphetamine, benzodiazepines, barbiturates, phencyclidine (PCP) or opiates at Baseline, except those receiving stable, prescribed treatment for attention deficit/hyperactivity disorder (ADHD) Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any other psychotic disorder. Unable to swallow tablets. Known hypersensitivity to any of ecopipam's excipients. History of seizures (excluding febrile seizures that occurred >2 years prior to Baseline). Myocardial infarction within 6 months from Screening.

Sites / Locations

  • Access Clinical Trials, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ecopipam 1.8 mg/kg/day

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a subject administered a study drug and which does not necessarily have a causal relationship with this treatment. A TEAE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
August 28, 2023
Sponsor
Emalex Biosciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06021522
Brief Title
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder
Official Title
A Multicenter, Open-Label, Study to Evaluate the Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emalex Biosciences Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS).
Detailed Description
This study is to evaluate the long-term safety and tolerability of ecopipam tablets in eligible participants. The eligible participants will be entered into a treatment period and start a 4-week titration phase to achieve a target steady-state dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day dose of ecopipam HCl). During the 4-week titration phase ecopipam will be dispensed following weight bands before reaching their respective maintenance dose until end of the treatment. Safety assessment will be conducted at baseline visit and at all treatment visits (Months 1-12, 15, 18, 21 and 24). Safety follow up visits will be conducted 7 and 14 days and a follow up phone call will be conducted 30 days after the last dose of ecopipam.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Ecopipam, Neurodevelopmental Disorders, Mental Disorders, Central Nervous System Depressants, Neurodegenerative Diseases, Movement Disorders, Tic Disorders, Nervous System Diseases, Central Nervous System Diseases, Brain Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ecopipam 1.8 mg/kg/day
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ecopipam
Other Intervention Name(s)
Ecopipam Hydrochloride
Intervention Description
Selective dopamine D1 and D5 receptor antagonist
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a subject administered a study drug and which does not necessarily have a causal relationship with this treatment. A TEAE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product.
Time Frame
Baseline up to Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >=6 to >=18 years of age. Participants enrolling from the study EBS-101-TD-301; completed all visits through Week 24 and days 7 and 14 safety follow-up, met relapse criteria during the double-blind randomized (R/WD) period after completing the 301 end of trial (ET) visit, the 7 day and 14 day safety follow up visits, but not before 24 weeks following the 301 baseline visit or participants who met relapse criteria will be eligible after completing early termination visit, Day 7 and Day 14 follow up visits. Participants who completed the studies EBS-101-OL-001 or PSY302A. The enrolling participant must have had clinical benefit from ecopipam and would benefit from continued participation. Effective contraception during the study and 30 days after last study dose for sexually active participants <18 years of age participants parent/legal guardian must sign a written informed consent and participant must sign a written informed assent. Participant must have TD based on Diagnostic and Statistical Manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD. TD diagnosis and both motor and vocal tics that cause impairment with normal routines Exclusion Criteria: The participants who discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent, non-compliant or withdrawn by the discretion of either the site investigator or the sponsor. Participants with ongoing or past history of neurological condition (example [e.g.], Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless Legs Syndrome). Any unstable mood disorder (DSM-5-TR criteria), mental illness or clinically significant lab abnormalities, moderate to severe renal or hepatic impairment, a PHQ-9 score >=10 at screening and history of neuroleptic malignant syndrome at the time of screening or baseline. Participants who completed the studies EBS-101-OL-001 or PSY-302A and who had previous exposure to ecopipam and oral neuroleptics within 4 weeks and depot neuroleptics within 3 months prior to screening, 6 months prior to Baseline. Participants receiving any other medication to treat motor or vocal tics and anti-depressant or anti-anxiety medications. Risk of suicide as per PI judgement Pregnant or lactating women Certain medications that would have unfavorable drug interactions with ecopipam, e.g., digoxin, fluoxetine, valproic acid, bupropion. Current or recent (past 3 months) DSM-5-TR substance use disorder (with the exception of nicotine). Recent behavioral therapy Positive urine drug screen for cocaine, amphetamine, benzodiazepines, barbiturates, phencyclidine (PCP) or opiates at Baseline, except those receiving stable, prescribed treatment for attention deficit/hyperactivity disorder (ADHD) Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any other psychotic disorder. Unable to swallow tablets. Known hypersensitivity to any of ecopipam's excipients. History of seizures (excluding febrile seizures that occurred >2 years prior to Baseline). Myocardial infarction within 6 months from Screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith M Miller
Phone
773 343 0671
Email
mmiller@emalexbiosciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
David JB Kim
Phone
312 847 1342
Email
dkim@emalexbiosciences.com
Facility Information:
Facility Name
Access Clinical Trials, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-6502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James (Alan) Fry, MD
Phone
615-320-6076
Email
drafry@accessclintrials.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

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