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出境医 / 临床实验 / Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (D1AMOND)
Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (D1AMOND)
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tourette Syndrome in Children; Tourette Syndrome in Adolescents | Drug: Ecopipam | Phase 2 |
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
| 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 |
Arms and Interventions
| 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
|
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
|
Drug: Ecopipam
Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo
|
Outcome Measures
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)
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: David Kim | 847-715-0562 | dkim@emalexbiosciences.com | |
| Contact: Meredith Miller | mmiller@emalexbiosciences.com |
Locations
Show 79 study locations
Sponsors and Collaborators
Emalex Biosciences Inc.
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 2, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | April 21, 2021 | ||||||||
| Actual Study Start Date ICMJE | June 20, 2019 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Tourette Syndrome in Children; Tourette Syndrome in Adolescents | ||||||||
| Intervention ICMJE | Drug: Ecopipam
Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
150 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 2021 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 6 Years to 17 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada, France, Germany, Hungary, Italy, Poland, United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04007991 | ||||||||
| Other Study ID Numbers ICMJE | EBS-101-CL-001 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Emalex Biosciences Inc. | ||||||||
| Study Sponsor ICMJE | Emalex Biosciences Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Emalex Biosciences Inc. | ||||||||
| Verification Date | October 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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