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

September 8, 2023 updated by: Emalex Biosciences Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • The Kids Clinic Inc
      • Ottawa, Ontario, Canada, K2G 1W2
        • Center for Pediatric Excellence
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
  • France
      • Poitiers, France, 86021
        • CHU Poitiers
    • Ile De France
      • Paris, Ile De France, France, 75019
        • Hôpital Robert Debré
  • Germany
      • Freiburg, Germany, 79104
        • Dept. Child Adolescent Psychiatry Uni. Freiburg
      • Mannheim, Germany, 68159
        • Zentralinstitut fuer Seelische Gesundheit
      • Mittweida, Germany, 09648
        • Pharmakologisches Studienzentrum Chemnitz GmbH
    • Bayern
      • Muenchen, Bayern, Germany, 80336
        • Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk, Poland, 80-546
        • Centrum Bada Klinicznych PI-House Sp. z o.o.
      • Gdańsk, Poland, 80-542
        • Gdanskie Centrum Zdrowia Sp z o.o.
      • Katowice, Poland, 40-123
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
      • Krakow, Poland, 30-363
        • Centrum Medyczne Plejady
      • Krakow, Poland, 31-503
        • Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
      • Poznań, Poland, 60-693
        • Med-Polonia Sp. z o. o.
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Harmonex Neuroscience Research
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center Inc.
      • Los Angeles, California, United States, 90095
        • UCLA
      • San Diego, California, United States, 92108
        • PCSD-Feighner Research
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Gulf Breeze, Florida, United States, 32561
        • Northwest Florida Clinical Research Group, LLC
      • Hialeah, Florida, United States, 33013
        • Research in Miami Inc.
      • Miami, Florida, United States, 33136
        • University of Miami
      • North Miami, Florida, United States, 33180
        • MedBio Trials
      • Orlando, Florida, United States, 32803
        • APG Research LLC
      • Saint Petersburg, Florida, United States, 33701-4825
        • University of South Florida
      • Tampa, Florida, United States, 33609-4181
        • Pediatric Epilepsy and Neurology Specialists
      • Winter Park, Florida, United States, 32789
        • Pediatric Neurology, PA
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Rare Disease Research, LLC
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60612-3841
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637-1447
        • The University of Chicago Hospitals
      • Naperville, Illinois, United States, 60563-6510
        • AMR - Baber Research Inc.
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Psychiatric Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Michigan Clinical Research Institute PC
      • Bloomfield Hills, Michigan, United States, 48302-1952
        • Neurobehavioral Medicine Group
      • Wyoming, Michigan, United States, 49418
        • Helen DeVos Children's Hospital / Spectrum Health Medical Group
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • St. Charles Psychiatric Associates dba Midwest Research Group
      • Saint Louis, Missouri, United States, 63110-1093
        • Movement Disorders Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Alivation Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center for Psychiatry And Behavioral Medicine Inc.
    • New Jersey
      • Mount Arlington, New Jersey, United States, 07856
        • The NeuroCognitive Institute
      • Voorhees, New Jersey, United States, 08043-1910
        • Clinical Research Center of Nj
    • New York
      • New York, New York, United States, 10003
        • New York Neurology Associates P.C
      • New York, New York, United States, 10019
        • Hapworth Research Inc.
      • New York, New York, United States, 10029-6504
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10036
        • Mood Disorders Consulting Medicine PLLC
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • Ohio
      • Avon Lake, Ohio, United States, 44012-1004
        • Quest Therapeutics of Avon Lake
      • Cincinnati, Ohio, United States, 45229-3026
        • Cincinnati Childrens Hospital Medical Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Middleburg Heights, Ohio, United States, 44130
        • North Star Medical Research LLC
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203-6502
        • Access Clinical Trials, Inc.
      • Nashville, Tennessee, United States, 37232-0028
        • Vanderbilt University Medical Center
    • Texas
      • Bellaire, Texas, United States, 77401
        • Houston Clinical Trials LLC
      • Dallas, Texas, United States, 75243
        • Relaro Medical Trials
      • Fort Worth, Texas, United States, 76104
        • North Texas Clinical Trials
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78249-3539
        • Road Runner Research Ltd.
    • Utah
      • Springville, Utah, United States, 84663
        • Noetic Psychiatry
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0829
        • University of Virginia
    • Washington
      • Everett, Washington, United States, 98201-4077
        • Eastside Therapeutic Resource Inc dba Core Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matching Placebo tablets taken orally in the evening
Drug: Placebo
Matching Placebo
Experimental: Ecopipam HCI 2 mg/kg/day
Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings
Drug: Ecopipam
Ecopipam HCI tablets administered PO to establish 2 mg/kg/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12
Time Frame: Baseline, 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.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12
Time Frame: Baseline, 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.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emalex Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBS-101-CL-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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