Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (D1AMOND)
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| ClinicalTrials.gov Identifier: NCT04007991 |
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Recruitment Status :
Recruiting
First Posted : July 5, 2019
Last Update Posted : March 9, 2021
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Sponsor:
Emalex Biosciences Inc.
Information provided by (Responsible Party):
Emalex Biosciences Inc.
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tourette Syndrome in Children; Tourette Syndrome in Adolescents | Drug: Ecopipam | Phase 2 |
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 : | 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Tourette syndrome
MedlinePlus related topics:
Tourette Syndrome
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
Primary Outcome Measures :
- 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 |
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
Information from the National Library of Medicine
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
Contacts
| Contact: David Kim | 847-715-0562 | dkim@emalexbiosciences.com | |
| Contact: Meredith Miller | mmiller@emalexbiosciences.com |
Locations
Show 77 study locations
Sponsors and Collaborators
Emalex Biosciences Inc.
| 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: | March 9, 2021 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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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 |