Tourette SyndromePhase 2D1AMONDNCT04007991
Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
A Phase 2 study testing Ecopipam in people with Tourette Syndrome, run by Emalex Biosciences Inc. at 70 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Ecopipam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 70 sitesin 5 countries
- Study dates
- 28 Jun 2019to 23 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 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
Who cannot join
- 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
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- 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
Trial locations and contacts
70 sites in 5 countries.
70 sites in 5 countries
United States53 sites
Advanced Research Center Inc.
Anaheim, California, 92805
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, 48105
Rare Disease Research, LLC
Atlanta, Georgia, 30318
Quest Therapeutics of Avon Lake
Avon Lake, Ohio, 44012-1004
Houston Clinical Trials LLC
Bellaire, Texas, 77401
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302-1952
Massachusetts General Hospital
Boston, Massachusetts, 02114
Coastal Pediatric Research
Charleston, South Carolina, 29414
University of Virginia
Charlottesville, Virginia, 22908-0829
Rush University Medical Center
Chicago, Illinois, 60612-3841
The University of Chicago Hospitals
Chicago, Illinois, 60637-1447
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229-3026
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Relaro Medical Trials
Dallas, Texas, 75243
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Eastside Therapeutic Resource Inc dba Core Clinical Research
Everett, Washington, 98201-4077
North Texas Clinical Trials
Fort Worth, Texas, 76104
Sarkis Clinical Trials
Gainesville, Florida, 32607
Northwest Florida Clinical Research Group, LLC
Gulf Breeze, Florida, 32561
Research in Miami Inc.
Hialeah, Florida, 33013
Baylor College of Medicine
Houston, Texas, 77030
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128
Alivation Research, LLC
Lincoln, Nebraska, 68526
UCLA
Los Angeles, California, 90095
Suburban Research Associates
Media, Pennsylvania, 19063
University of Miami
Miami, Florida, 33136
North Star Medical Research LLC
Middleburg Heights, Ohio, 44130
The NeuroCognitive Institute
Mount Arlington, New Jersey, 07856
AMR - Baber Research Inc.
Naperville, Illinois, 60563-6510
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203-6502
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0028
Yale School of Medicine
New Haven, Connecticut, 06519
New York Neurology Associates P.C
New York, New York, 10003
Hapworth Research Inc.
New York, New York, 10019
Mount Sinai School of Medicine
New York, New York, 10029-6504
Mood Disorders Consulting Medicine PLLC
New York, New York, 10036
MedBio Trials
North Miami, Florida, 33180
APG Research LLC
Orlando, Florida, 32803
Psychiatric Associates
Overland Park, Kansas, 66211
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Finger Lakes Clinical Research
Rochester, New York, 14618
St. Charles Psychiatric Associates dba Midwest Research Group
Saint Charles, Missouri, 63304
Road Runner Research Ltd.
San Antonio, Texas, 78249-3539
PCSD-Feighner Research
San Diego, California, 92108
Syrentis Clinical Research
Santa Ana, California, 92705
Meridian Clinical Research
Savannah, Georgia, 31406
Noetic Psychiatry
Springville, Utah, 84663
Movement Disorders Center
St Louis, Missouri, 63110-1093
University of South Florida
St. Petersburg, Florida, 33701-4825
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33609-4181
Clinical Research Center of NJ
Voorhees Township, New Jersey, 08043-1910
Pediatric Neurology, PA
Winter Park, Florida, 32789
Helen DeVos Children's Hospital / Spectrum Health Medical Group
Wyoming, Michigan, 49418
Poland7 sites
Gdanskie Centrum Zdrowia Sp z o.o.
Gdansk, 80-542
Centrum Bada Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice, 40-123
Centrum Medyczne Plejady
Krakow, 30-363
Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
Krakow, 31-503
Med-Polonia Sp. z o. o.
Poznan, 60-693
Germany5 sites
Dept. Child Adolescent Psychiatry Uni. Freiburg
Freiburg im Breisgau, 79104
Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
Hanover, Lower Saxony, 30625
Zentralinstitut fuer Seelische Gesundheit
Mannheim, 68159
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, 09648
Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
Munich, Bavaria, 80336
Canada3 sites
The Kids Clinic Inc
Ajax, Ontario, L1Z 0M1
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Center for Pediatric Excellence
Ottawa, Ontario, K2G 1W2
France2 sites
Hopital Robert Debre
Paris, Île-de-France Region, 75019
CHU Poitiers
Poitiers, 86021
About this study
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
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
Read the 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.
- Conditions
- Tourette Syndrome
- Being tested
- Ecopipam, Placebo
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcopipamDrug
Ecopipam HCI tablets administered PO to establish 2 mg/kg/day
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ecopipam HCI 2 mg/kg/day | Experimental | Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings Receives: Drug: Ecopipam |
| Placebo | Placebo comparator | Matching Placebo tablets taken orally in the evening Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (1)
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.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start28 Jun 2019
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007991
- Sponsor's protocol ID
- EBS-101-CL-001
- Acronym
- D1AMOND
- Status last verified
- Sep 2023
- First submitted
- 2 Jul 2019
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04007991
- Acronym / sponsor ID
- D1AMOND / EBS-101-CL-001
- Conditions
- Tourette Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ecopipam HCI 2 mg/kg/day | Experimental | Drug: EcopipamEcopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo tablets taken orally in the evening |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EcopipamEcopipam HCI tablets administered PO to establish 2 mg/kg/day | Drug | Ecopipam HCI 2 mg/kg/day |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Change From Baseline in Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S) at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
70 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ecopipam in people with Tourette Syndrome, run by Emalex Biosciences Inc. at 70 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Poland, Germany, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.