Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (D1AMOND)
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ClinicalTrials.gov Identifier: NCT04007991 |
Recruitment Status :
Recruiting
First Posted : July 5, 2019
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tourette Syndrome in Children; Tourette Syndrome in Adolescents | Drug: Ecopipam | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 20, 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | October 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Ecopipam 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
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Drug: Ecopipam
Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo |
Placebo Comparator: Placebo
Matching Placebo tablets taken orally in the evening
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Drug: Ecopipam
Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo |
- Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Screening through Week 12 ]Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007991
Contact: David Kim | 847-715-0562 | dkim@emalexbiosciences.com | |
Contact: Meredith Miller | mmiller@emalexbiosciences.com |

Responsible Party: | Emalex Biosciences Inc. |
ClinicalTrials.gov Identifier: | NCT04007991 |
Other Study ID Numbers: |
EBS-101-CL-001 |
First Posted: | July 5, 2019 Key Record Dates |
Last Update Posted: | October 8, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Tourette Syndrome Syndrome Disease Pathologic Processes Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Tic Disorders Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn |
Neurodevelopmental Disorders Mental Disorders Ecopipam Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |