Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults (D1AMOND)
Tourette Disorder
About this trial
This is an interventional treatment trial for Tourette Disorder
Eligibility Criteria
Inclusion Criteria: ≥ 6 years of age ≥ 18 kg (~ 40 lbs.) TD diagnosis and both motor and vocal tics that cause impairment with normal routines Minimum score of 20 on the YGTSS-R 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: Previous exposure to ecopipam Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder) Unstable 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
Sites / Locations
- Harmonex Neuroscience ResearchRecruiting
- Syrentis Clinical ResearchRecruiting
- Yale School of MedicineRecruiting
- University of FloridaRecruiting
- University of FloridaRecruiting
- NW FL Clinical Research Group, LLCRecruiting
- Research in Miami IncRecruiting
- APG Research LLCRecruiting
- Pediatric Epilepsy and Neurology SpecialistsRecruiting
- Pediatric Neurology, PARecruiting
- Atlanta Behavioral Research, LLC.Recruiting
- Chicago Research CenterRecruiting
- The University of Chicago HospitalsRecruiting
- Josephson-Wallack-Munshower NeurologyRecruiting
- Massachusetts General HospitalRecruiting
- Boston Children's HospitalRecruiting
- Michigan Clinical Research Institute PCRecruiting
- Neurobehavioral Medicine GroupRecruiting
- Washington University School of MedicineRecruiting
- Alivation Research, LLCRecruiting
- Alivation ResearchRecruiting
- Mount Sinai School of MedicineRecruiting
- Wake Forest Baptist Medical Center - PPDSRecruiting
- Cincinnati Childrens Hospital Medical CenterRecruiting
- Suburban Research AssociatesRecruiting
- Coastal Pediatric ResearchRecruiting
- Access Clinical Trials, Inc.Recruiting
- Vanderbilt University Medical CenterRecruiting
- Baylor College of MedicineRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- Road Runner Research Ltd.Recruiting
- Cedar Clinical ResearchRecruiting
- Core Clinical ResearchRecruiting
- Center Spectar-PlovdivRecruiting
- Kalimat Medical Center_SofiaRecruiting
- DCC Mladost-M VarnaRecruiting
- University of CalgaryRecruiting
- The Kids Clinic IncRecruiting
- Center for Pediatric ExcellenceRecruiting
- Wielospecjalistyczna Poradnia Lekarska SynapsisRecruiting
- Centrum Medyczne PlejadyRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)
Placebo during R/WD Phase
Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.
Matching Placebo tablets during R/WD period taken orally in the evening.