A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder
Purpose
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).
Condition
- Tourette Syndrome
Eligibility
- Eligible Ages
- Over 6 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent, non-compliant or withdrawn by the discretion of either the site investigator or the sponsor.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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ecopipam 1.8 mg/kg/day |
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. |
|
Recruiting Locations
Harmonex, Inc.
Dothan, Alabama 36303
Dothan, Alabama 36303
Advanced Research Center
Anaheim, California 92805
Anaheim, California 92805
CenExel CIT-IE
Bellflower, California 90706
Bellflower, California 90706
Cortica Site Network
Glendale, California 91203
Glendale, California 91203
Cortica Site Network - San Rafael
San Rafael, California 94903
San Rafael, California 94903
Yale School of Medicine
New Haven, Connecticut 06519
New Haven, Connecticut 06519
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida 32561
Gulf Breeze, Florida 32561
Research in Miami Inc
Hialeah, Florida 33013-3834
Hialeah, Florida 33013-3834
University of Miami Miller School of Medicine
Miami, Florida 33136
Miami, Florida 33136
Florida International Research Center
Miami, Florida 33173
Miami, Florida 33173
APG Research, LLC
Orlando, Florida 32803
Orlando, Florida 32803
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida 33609
Tampa, Florida 33609
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
Josephson-Wallack-Munshower Neurology
Indianapolis, Indiana 46256
Indianapolis, Indiana 46256
Mass General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Boston Childrens Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Michigan Clinical research Institute PC
Ann Arbor, Michigan 48105
Ann Arbor, Michigan 48105
Neurobahavioral Medicine Group
Bloomfield Hills, Michigan 48302
Bloomfield Hills, Michigan 48302
St. Louis Children's Hospital
St. Louis, Missouri 63110
St. Louis, Missouri 63110
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Coastal Pediatric Research
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Access Clinical Trials, Inc.
Nashville, Tennessee 37203-6502
Nashville, Tennessee 37203-6502
Access Clinical Trials, Inc.
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Vanderbilt University Medical Center
Nashville, Tennessee 37232-2551
Nashville, Tennessee 37232-2551
The University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
Road Runner Research, Ltd
San Antonio, Texas 78249
San Antonio, Texas 78249
Cedar Clinical Research
Draper, Utah 84020
Draper, Utah 84020
Core Clinical Research
Everett, Washington 98201
Everett, Washington 98201
More Details
- NCT ID
- NCT06021522
- Status
- Recruiting
- Sponsor
- Emalex Biosciences Inc.
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.