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Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (D1AMOND)

Primary Purpose

Tourette Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ecopipam
Placebo
Sponsored by
Emalex Biosciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 6 and < 18 years of age
  • ≥ 18 kg (~ 40 lbs.)
  • TS diagnosis and both motor and vocal tics that cause impairment with normal routines
  • Minimum score of 20 on the YGTSS-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:

  • Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
  • 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 Research
  • Phoenix Children's Hospital
  • Advanced Research Center Inc.
  • UCLA
  • PCSD-Feighner Research
  • Syrentis Clinical Research
  • Yale School of Medicine
  • Sarkis Clinical Trials
  • Northwest Florida Clinical Research Group, LLC
  • Research in Miami Inc.
  • University of Miami
  • MedBio Trials
  • APG Research LLC
  • University of South Florida
  • Pediatric Epilepsy and Neurology Specialists
  • Pediatric Neurology, PA
  • Rare Disease Research, LLC
  • Meridian Clinical Research
  • Rush University Medical Center
  • The University of Chicago Hospitals
  • AMR - Baber Research Inc.
  • Psychiatric Associates
  • Massachusetts General Hospital
  • Michigan Clinical Research Institute PC
  • Neurobehavioral Medicine Group
  • Helen DeVos Children's Hospital / Spectrum Health Medical Group
  • St. Charles Psychiatric Associates dba Midwest Research Group
  • Movement Disorders Center
  • Alivation Research, LLC
  • Center for Psychiatry and Behavioral Medicine Inc.
  • The NeuroCognitive Institute
  • Clinical Research Center of NJ
  • New York Neurology Associates P.C
  • Hapworth Research Inc.
  • Mount Sinai School of Medicine
  • Mood Disorders Consulting Medicine PLLC
  • Finger Lakes Clinical Research
  • Quest Therapeutics of Avon Lake
  • Cincinnati Childrens Hospital Medical Center
  • University Hospitals Cleveland Medical Center
  • North Star Medical Research LLC
  • Suburban Research Associates
  • Coastal Pediatric Research
  • Access Clinical Trials, Inc.
  • Vanderbilt University Medical Center
  • Houston Clinical Trials LLC
  • Relaro Medical Trials
  • North Texas Clinical Trials
  • Baylor College of Medicine
  • Road Runner Research Ltd.
  • Noetic Psychiatry
  • University of Virginia
  • Eastside Therapeutic Resource Inc dba Core Clinical Research
  • The Kids Clinic Inc
  • Center for Pediatric Excellence
  • CHU Sainte-Justine
  • Hopital Robert Debre
  • CHU Poitiers
  • Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
  • Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
  • Dept. Child Adolescent Psychiatry Uni. Freiburg
  • Zentralinstitut fuer Seelische Gesundheit
  • Pharmakologisches Studienzentrum Chemnitz GmbH
  • Centrum Bada Klinicznych PI-House Sp. z o.o.
  • Uniwersyteckie Centrum Kliniczne
  • Gdanskie Centrum Zdrowia Sp z o.o.
  • NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
  • Centrum Medyczne Plejady
  • Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
  • Med-Polonia Sp. z o. o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ecopipam HCI 2 mg/kg/day

Placebo

Arm Description

Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings

Matching Placebo tablets taken orally in the evening

Outcomes

Primary Outcome Measures

Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12
The YGTSS was a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0=none to 5=severe for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms. A negative change from baseline indicates improvement.

Secondary Outcome Measures

Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12
Clinical Global Impression (CGI) scale was used to assess overall severity on a 7-point Likert scale consisted of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The CGI severity scale ranges from 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill subject. 1 = "normal, not ill at all" to 7 = "extremely ill." A negative change indicates improvement in the condition.

Full Information

First Posted
July 2, 2019
Last Updated
September 8, 2023
Sponsor
Emalex Biosciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04007991
Brief Title
Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
Acronym
D1AMOND
Official Title
Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

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

5. Study Description

Brief Summary
This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets
Detailed Description
Multicenter, placebo-controlled, double-blind, randomized, parallel-group, Phase 2b study in pediatric subjects (aged greater than equal to 6 to less than 18 years of age) with TS. Following a 28-day Screening period and Baseline visit, eligible subjects will be randomized 1:1 to receive either ecopipam hydrochloride (HCl) or matching placebo for a 12 week treatment period. Doses will be titrated up and down from target dose of 2 mg/kg/day. Follow Up visit will be conducted after the last dose of study medication.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ecopipam HCI 2 mg/kg/day
Arm Type
Experimental
Arm Description
Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo tablets taken orally in the evening
Intervention Type
Drug
Intervention Name(s)
Ecopipam
Intervention Description
Ecopipam HCI tablets administered PO to establish 2 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12
Description
The YGTSS was a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0=none to 5=severe for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The total tic score (TTS) ranged from 0 (none) to 50 (severe) with higher score represent more severe symptoms. A negative change from baseline indicates improvement.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12
Description
Clinical Global Impression (CGI) scale was used to assess overall severity on a 7-point Likert scale consisted of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The CGI severity scale ranges from 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill subject. 1 = "normal, not ill at all" to 7 = "extremely ill." A negative change indicates improvement in the condition.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 6 and < 18 years of age ≥ 18 kg (~ 40 lbs.) TS diagnosis and both motor and vocal tics that cause impairment with normal routines Minimum score of 20 on the YGTSS-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: Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) 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
Facility Information:
Facility Name
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Advanced Research Center Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
PCSD-Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Northwest Florida Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Research in Miami Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
MedBio Trials
City
North Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
APG Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of South Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701-4825
Country
United States
Facility Name
Pediatric Epilepsy and Neurology Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4181
Country
United States
Facility Name
Pediatric Neurology, PA
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Rare Disease Research, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3841
Country
United States
Facility Name
The University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1447
Country
United States
Facility Name
AMR - Baber Research Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563-6510
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Michigan Clinical Research Institute PC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Neurobehavioral Medicine Group
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302-1952
Country
United States
Facility Name
Helen DeVos Children's Hospital / Spectrum Health Medical Group
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49418
Country
United States
Facility Name
St. Charles Psychiatric Associates dba Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Movement Disorders Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
The NeuroCognitive Institute
City
Mount Arlington
State/Province
New Jersey
ZIP/Postal Code
07856
Country
United States
Facility Name
Clinical Research Center of NJ
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043-1910
Country
United States
Facility Name
New York Neurology Associates P.C
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Hapworth Research Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6504
Country
United States
Facility Name
Mood Disorders Consulting Medicine PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Quest Therapeutics of Avon Lake
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012-1004
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3026
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
North Star Medical Research LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Access Clinical Trials, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-6502
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0028
Country
United States
Facility Name
Houston Clinical Trials LLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Relaro Medical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Road Runner Research Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249-3539
Country
United States
Facility Name
Noetic Psychiatry
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0829
Country
United States
Facility Name
Eastside Therapeutic Resource Inc dba Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201-4077
Country
United States
Facility Name
The Kids Clinic Inc
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Facility Name
Center for Pediatric Excellence
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 1W2
Country
Canada
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Hopital Robert Debre
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75019
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Dept. Child Adolescent Psychiatry Uni. Freiburg
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Zentralinstitut fuer Seelische Gesundheit
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz GmbH
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Centrum Bada Klinicznych PI-House Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Gdanskie Centrum Zdrowia Sp z o.o.
City
Gdańsk
ZIP/Postal Code
80-542
Country
Poland
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Facility Name
Med-Polonia Sp. z o. o.
City
Poznań
ZIP/Postal Code
60-693
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents

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