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Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults (D1AMOND)

Primary Purpose

Tourette Disorder

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

About this trial

This is an interventional treatment trial for Tourette Disorder

Eligibility Criteria

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

Inclusion Criteria: ≥ 6 years of age ≥ 18 kg (~ 40 lbs.) TD diagnosis and both motor and vocal tics that cause impairment with normal routines Minimum score of 20 on the YGTSS-R Total Tic Score May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline. Effective contraception during the study and 30 days after last study dose for sexually active subjects Exclusion Criteria: Previous exposure to ecopipam Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) Unstable unstable medical illness or clinically significant lab abnormalities Risk of suicide Pregnant or lactating women Moderate to severe renal insufficiency Hepatic insufficiency Positive urine drug screen Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder Certain medications that would lead to drug interactions Recent behavioral therapy

Sites / Locations

  • Harmonex Neuroscience ResearchRecruiting
  • Syrentis Clinical ResearchRecruiting
  • Yale School of MedicineRecruiting
  • University of FloridaRecruiting
  • University of FloridaRecruiting
  • NW FL Clinical Research Group, LLCRecruiting
  • Research in Miami IncRecruiting
  • APG Research LLCRecruiting
  • Pediatric Epilepsy and Neurology SpecialistsRecruiting
  • Pediatric Neurology, PARecruiting
  • Atlanta Behavioral Research, LLC.Recruiting
  • Chicago Research CenterRecruiting
  • The University of Chicago HospitalsRecruiting
  • Josephson-Wallack-Munshower NeurologyRecruiting
  • Massachusetts General HospitalRecruiting
  • Boston Children's HospitalRecruiting
  • Michigan Clinical Research Institute PCRecruiting
  • Neurobehavioral Medicine GroupRecruiting
  • Washington University School of MedicineRecruiting
  • Alivation Research, LLCRecruiting
  • Alivation ResearchRecruiting
  • Mount Sinai School of MedicineRecruiting
  • Wake Forest Baptist Medical Center - PPDSRecruiting
  • Cincinnati Childrens Hospital Medical CenterRecruiting
  • Suburban Research AssociatesRecruiting
  • Coastal Pediatric ResearchRecruiting
  • Access Clinical Trials, Inc.Recruiting
  • Vanderbilt University Medical CenterRecruiting
  • Baylor College of MedicineRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Road Runner Research Ltd.Recruiting
  • Cedar Clinical ResearchRecruiting
  • Core Clinical ResearchRecruiting
  • Center Spectar-PlovdivRecruiting
  • Kalimat Medical Center_SofiaRecruiting
  • DCC Mladost-M VarnaRecruiting
  • University of CalgaryRecruiting
  • The Kids Clinic IncRecruiting
  • Center for Pediatric ExcellenceRecruiting
  • Wielospecjalistyczna Poradnia Lekarska SynapsisRecruiting
  • Centrum Medyczne PlejadyRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)

Placebo during R/WD Phase

Arm Description

Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.

Matching Placebo tablets during R/WD period taken orally in the evening.

Outcomes

Primary Outcome Measures

Yale Global Tic Severity Scale (YGTSS)
Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
October 13, 2023
Sponsor
Emalex Biosciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05615220
Brief Title
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Acronym
D1AMOND
Official Title
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (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
Yes

5. Study Description

Brief Summary
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Detailed Description
Following a 28-day Screening period and Baseline visit, eligible subjects will be enrolled into the open-label Stabilization period comprised of a 4-week Titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) followed by an 8-week open-label Maintenance phase. Responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam HCl) or placebo in a 1:1 fashion and enter the double-blind Randomized-Withdrawal (R/WD) period at Week 12. During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
This is a multicenter study which includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Masking
ParticipantCare ProviderInvestigator
Masking Description
This includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)
Arm Type
Experimental
Arm Description
Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.
Arm Title
Placebo during R/WD Phase
Arm Type
Placebo Comparator
Arm Description
Matching Placebo tablets during R/WD period taken orally in the evening.
Intervention Type
Drug
Intervention Name(s)
Ecopipam Hydrochloride
Intervention Description
Selective dopamine D1 and D5 receptor antagonist
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale (YGTSS)
Description
Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)
Time Frame
Screening up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 6 years of age ≥ 18 kg (~ 40 lbs.) TD diagnosis and both motor and vocal tics that cause impairment with normal routines Minimum score of 20 on the YGTSS-R Total Tic Score May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline. Effective contraception during the study and 30 days after last study dose for sexually active subjects Exclusion Criteria: Previous exposure to ecopipam Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) Unstable unstable medical illness or clinically significant lab abnormalities Risk of suicide Pregnant or lactating women Moderate to severe renal insufficiency Hepatic insufficiency Positive urine drug screen Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder Certain medications that would lead to drug interactions Recent behavioral therapy
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
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelson Handal-Thome, MD
Phone
334-836-2000
Email
nhandal@harmonex.us
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Duffy, MD
Phone
714-542-3008
Email
JohnGDuffyMD@gmail.com
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bloch, MD
Phone
203-745-9921
Email
michael.bloch@yale.edu
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Malaty, MD
Phone
352-273-5550
Email
irene.malaty@neurology.ufl.edu
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Malaty
Phone
352-273-5550
Email
irene.malaty@neurology.ufl.edu
Facility Name
NW FL Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weldon Mauney, MD
Phone
850-934-1299
Email
wmauney@nwflcrg.com
Facility Name
Research in Miami Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013-3834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Sanchez Cazau
Phone
305-889-6670
Email
dcazau@researchinmiami.com
Facility Name
APG Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morteza Nadjafi, MD
Phone
407-921-2448
Email
MORIAPG@GMAIL.COM
Facility Name
Pediatric Epilepsy and Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4181
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Ferreira, MD
Phone
813-873-7367
Email
mayra@pensresearch.org
Facility Name
Pediatric Neurology, PA
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Davis, MD
Phone
407-293-1122
Email
rgdavis@pediaticneurologypa.com
Facility Name
Atlanta Behavioral Research, LLC.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suneel Katragadda, MD
Phone
770-458-0448
Email
skatragadda@gapsychiatry.com
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Jaffe, MD
Phone
773-282-9845
Email
monika.jaffe@chicagoresearchcenter.com
Facility Name
The University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1447
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Grant, MD
Phone
773-834-1325
Email
jongrant@uchicago.edu
Facility Name
Josephson-Wallack-Munshower Neurology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Ridel, MD
Phone
317-537-6058
Email
ridelkands@gmail.com
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Geller, MD
Phone
617-724-5141
Email
dan.geller@mgh.harvard.edu
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kinga Tomczak, MD
Phone
617-355-2063
Email
kinga.tomczak@childrens.harvard.edu
Facility Name
Michigan Clinical Research Institute PC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajaprabhakaran Rajarethinam, MD
Phone
734-834-8954
Email
rpmmc@yahoo.com
Facility Name
Neurobehavioral Medicine Group
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302-1952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Jackson, MD
Phone
248-290-5400
Email
richardjackson2000@yahoo.com
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Black, MD
Phone
314-362-6281
Email
kevin@npg.wustl.edu
First Name & Middle Initial & Last Name & Degree
Nicole Bauer
Phone
314.747.3064
Email
nikkibauer@wustl.edu
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Duffy, MD
Phone
402-817-2235
Email
drduffy@alivation.com
Facility Name
Alivation Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Duffy, MD
Phone
402-817-2236
Email
drduffy@alivation.com
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Jaffe, MD
Facility Name
Wake Forest Baptist Medical Center - PPDS
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gautam Popli
Phone
336-716-8694
Email
gpopli@wakehealth.edu
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Gilbert, MD
Phone
513-636-4222
Email
donald.gilbert@cchmc.org
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivkumar S Hatti, MD
Phone
610-891-9024
Email
shatti@surburanresearch.com
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Lehman, MD
Phone
843-518-5642
Email
rebecca.lehman@uscmed.sc.edu
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
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Isaacs, MD
Phone
615-936-2025
Email
david.a.isaacs@vumc.org
First Name & Middle Initial & Last Name & Degree
Michelle Eckland
Phone
615-875-7394
Email
michelle.r.eckland.1@vumc.org
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arjun Tarakad, MD
Phone
713-798-5989
Email
tarakad@bcm.edu
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Nick Russo, MD
Phone
713-500-5511
Email
Sam.N.Russo@uth.tmc.edu
Facility Name
Road Runner Research Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249-3539
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Tomasovic
Phone
210-949-0505
Email
jtomasovic@rrresearchsa.com
Facility Name
Cedar Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reid Robison, MD
Phone
801-369-8989
Email
reid.robinson@numinus.com
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Knutson, MD
Email
drjames.knutson@ccrtrial.com
Facility Name
Center Spectar-Plovdiv
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay Popov, MD
Phone
359897967270
Email
nikpopov@abv.bg
Facility Name
Kalimat Medical Center_Sofia
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Mihaylova, MD
Phone
359888685723
Email
dr.mihaylova@gmail.com
Facility Name
DCC Mladost-M Varna
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petar Petrov, MD
Phone
359888940142
Email
pmdown@abv.bg
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justyna Sarna, MD
Phone
403-944-4364
Email
jrsarna@ucalgary.ca
Facility Name
The Kids Clinic Inc
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohail Khattak, MD
Phone
905 6834440
Email
skhattak@kidsclinic.ca
Facility Name
Center for Pediatric Excellence
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 1W2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
van Stralen Judy, MD
Phone
613 726-7436
Email
judy@cfpe.ca
Facility Name
Wielospecjalistyczna Poradnia Lekarska Synapsis
City
Katowice
State/Province
Silesia
ZIP/Postal Code
42-123
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Smilowski, MD
Phone
0048 500 282 494
Email
marek.smilowski2@gmail.com
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Zolnowska, MD
Phone
48608412910
Email
marta.zolnowska@gmail.com
Facility Name
Hospital Universitario Virgen del Rocío
City
C/Antonio Maura Montaner, S/n, Edificio IBiS
State/Province
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Mir Rivera
Phone
0034-955923039
Email
pmir@us.es

12. IPD Sharing Statement

Learn more about this trial

Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

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