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This study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.
This was an international, multicenter, open-label, long term extension study to evaluate the safety of ecopipam tablets for the treatment of pediatric subjects (aged ≥6 to ≤18 years at Baseline) with Tourette Syndrome. Participants who completed the Phase 2b, randomized, double-blind, efficacy and safety study (EBS-101-CL-001) without major reportable protocol deviations, and who met all the inclusion/exclusion criteria for this study were eligible to participate in this study. All participants were titrated to a target dose of 2 mg/kg/day as participants rolled over from the Phase 2b double-blind efficacy and safety study were tapered off study drug to maintain the blind from that study. Participants were to complete study visits every month for 1 year. Follow-up visits were conducted 7 and 14 days after the last dose of the study drug and a follow-up phone call was conducted 30 days after the last dose of study drug
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecopipam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecopipam | Drug | Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | An AE was any untoward medical condition that occurs in a participant while participating in this clinical study. It can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. The relationship of the study drug in causing or contributing to the AE whether unrelated, possibly related, or probably related was decided by investigator medical judgment. | From start of study drug administration until 30 days after last dose (Up to Month 13) |
| Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Basophils/Leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in basophils to leukocytes ratio is reported in terms of percentage of cells. | Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Eosinophils/Leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in eosinophils to leukocytes ratio is reported in terms of percentage of cells. | Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Erythrocytes | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter erythrocytes was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Yale Global Tic Severity Scale -Total Tic Score (YGTSS-TTS) at Months 1, 3, 6, 9 and 12 | The YGTSS was a clinician-completed rating scale used to quantify overall tic severity as well as specific subdomains of tic number, frequency, intensity, complexity and interference. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a total tic score ranging from 0 to 50. Higher scores represent more severe symptoms. A negative change from baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | United States | ||
| Phoenix Children's Hospital |
A total of 124 participants who completed the open-labelled study EBS-101-CL-001 (NCT04007991) and who met the inclusion/exclusion criteria for this study were enrolled in the current study and received study treatment. Of the 124 enrolled participants, 121 participants were included in the modified ITT (mITT) Set and Safety Set.
The study was conducted at 39 sites in United States, Canada and Poland from 4 October 2019 (first participant first visit) to 11 November 2022 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ecopipam HCl 2 mg/kg/Day | Participants received ecopipam hydrochloride (HCl) tablets at a targeted dose of 2 milligram per kilogram per day (mg/kg/day), orally, once daily for up to 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2021 | Nov 9, 2023 |
Open Label
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| Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Hematocrit | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter hematocrit was reported. | Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Hemoglobin | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter hemoglobin was reported. | Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Leukocytes and Platelets | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameters (Leukocytes and Platelets) expressed in 10^9 cells per liter were reported. | Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Lymphocytes/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in lymphocytes to leukocytes ratio is reported in terms of percentage of cells. | Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Monocytes/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in monocytes to leukocytes ratio is reported in terms of percentage of cells. | Baseline up to Month 12 |
| Change From Baseline in Hematology Parameters: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Neutrophils/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in neutrophils to leukocytes ratio is reported in terms of percentage of cells. | Baseline up to Month 12 |
| Change From Baseline in Serum Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Lactase Dehydrogenase | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, and lactate dehydrogenase) were reported. | Baseline up to Month 12 |
| Change From Baseline in Serum Chemistry Parameters: Albumin, Globulin and Protein | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (albumin, globulin and protein) were reported. | Baseline up to Month 12 |
| Change From Baseline in Serum Chemistry Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglyceride and Urea Nitrogen | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (bicarbonate, calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglyceride, urea nitrogen) expressed in millimoles per liter (mmol/L) were reported. | Baseline up to Month 12 |
| Change From Baseline in Serum Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (bilirubin, creatinine and direct bilirubin) expressed in micromole per liter (mcmol/L) were reported. | Baseline up to Month 12 |
| Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in HbA1c was reported. | Baseline up to Month 12 |
| Change From Baseline in Vital Signs Parameter: Diastolic Blood Pressure and Systolic Blood Pressure | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs parameters diastolic blood pressure and systolic blood pressure and according to the assessment position (supine and standing) expressed in millimeter(s) of mercury (mmHg) was reported. | Baseline up to Month 12 |
| Change From Baseline in Vital Signs Parameter: Pulse Rate | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital sign parameter pulse rate and according to assessment position (supine and standing) was reported. | Baseline up to Month 12 |
| Change From Baseline in Vital Signs Parameter: Body Mass Index [BMI] | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs parameter BMI was reported. | Baseline up to Month 12 |
| Change From Baseline in Vital Signs Parameter: Height | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs height was reported. | Baseline up to Month 12 |
| Change From Baseline in Vital Signs Parameter: Weight | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs parameter weight was reported. | Baseline up to Month 12 |
| Change From Baseline in Electrocardiogram (ECG) Values Parameters: Aggregate PR Interval, Aggregate QRS Duration, Aggregate QT Interval, and Aggregate QTc Interval | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change From Baseline in ECG parameters aggregate PR interval, aggregate QRS duration, aggregate QT interval, and aggregate QTc interval expressed in millisecond (msec) was reported. | Baseline to Month 12 |
| Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Physical examination included examination of the following body areas and systems: Head, Eyes, Ears, Nose, Mouth, Throat, Neck (including Thyroid), Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae and Others. Any clinically significant abnormalities in physical examination were judged by the investigator. Only non-zero values are reported. | Baseline up to Month 12 |
| Baseline up to Months 1, 3, 6, 9 and 12 |
| Change From Baseline in the Yale Global Tic Severity Scale - Impairment (YGTSS-I) at Months 1, 3, 6, 9 and 12 | The YGTSS was a clinician-completed rating scale used to quantify overall tic severity as well as specific subdomains of tic number, frequency, duration, intensity, and complexity. Each of these subdomains was scored, on 0 to 5 scale, separately for an overall impairment rating from (0 = ''none'' to 50 = ''severe''). Higher score represent more severe symptoms. A negative change from baseline indicates improvement. | Baseline up to Months 1, 3, 6, 9 and 12 |
| Change From Baseline in the Yale Global Tic Severity Scale - Global Score (YGTSS-GS) at Months 1, 3, 6, 9 and 12 | The YGTSS was a clinician-completed rating scale used to quantify overall tic severity as well as specific subdomains of tic number, frequency, duration, intensity, and complexity. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a tic severity score ranging from 0 to 50. The YGTSS also provides for an overall impairment rating (0 = ''none'' to 50 = ''severe''). YGTSS-GS is the total of YGTSS-TTS and YGTSS-I. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics. A negative change from baseline indicates improvement. | Baseline up to Months 1, 3, 6, 9 and 12 |
| Change From Baseline in Clinical Global Impression of Tourette Syndrome of Severity (CGI-TS-S) at Months 1, 3, 6, 9, 12 | The CGI consists of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The CGI severity scale (CGI-TS-S) ranges from 1 = "not ill at all" to 7 = "among the most extremely ill." Higher scores represent more severe symptoms. A negative change from baseline indicates improvement. | Baseline up to Months 1, 3, 6, 9, 12 |
| Clinical Global Impression Tourette Syndrome of Improvement (CGI-TS-I) Scores at Months 1, 3, 6, 9 and 12 | The CGI consists of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The scale ranges from 1 = "very much improved" to 7 = very much worse" for the CGI-TS-I. Higher score represent more severe symptoms. | Months 1, 3, 6, 9 and 12 |
| Change From Baseline in Gilles de la Tourette Syndrome-Quality of Life Scale for Children and Adolescents (C&A-GTS-QOL) Total Score at Months 1, 3, 6, 9 and 12 | The C&A-GTS-QOL was a 27-item questionnaire specific to TS patients that asks the patient to assess the extent to which their quality of life is impacted by their symptoms. The C&A-GTS-QOL consists of 6 subscales (cognitive [score range 0-32], coprophenomena [range 0-12], psychological [range 0-24], physical [range 0-12], obsessive-compulsive [range 0-16], and activities of daily living (ADL) [range 0-12] and uses a 5 point Likert scale ranging from no problem to extreme problem. Scores for six subscales were generated by summing items and, for ease of interpretation, transformation to a range of 0 to 100 (100* [(observed score-min possible score)/(max possible score-min possible score)]). Total score, resulted from sum of the subscale scores, was also normalized to a 0 to 100 range. Higher score indicated worst quality of life. A negative change from baseline indicates better quality of life. | Baseline up to Months 1, 3, 6, 9 and 12 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Advanced Research Center Inc. | Anaheim | California | 92805 | United States |
| UCLA | Los Angeles | California | 90095 | United States |
| PCSD-Feighner Research | San Diego | California | 92108 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06519 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Northwest Florida Clinical Research Group, LLC | Gulf Breeze | Florida | 32561 | United States |
| Research in Miami Inc. | Hialeah | Florida | 33013 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| MedBio Trials | North Miami | Florida | 33180 | United States |
| APG Research LLC | Orlando | Florida | 32803 | United States |
| University of South Florida | St. Petersburg | Florida | 33701-4825 | United States |
| Pediatric Epilepsy and Neurology Specialists | Tampa | Florida | 33609-4181 | United States |
| Pediatric Neurology, PA | Winter Park | Florida | 32789 | United States |
| Rare Disease Research, LLC | Atlanta | Georgia | 30318 | United States |
| Meridian Clinical Research | Savannah | Georgia | 31406 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612-3841 | United States |
| The University of Chicago Hospitals | Chicago | Illinois | 60637-1447 | United States |
| AMR - Baber Research Inc. | Naperville | Illinois | 60563-6510 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Michigan Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | United States |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302-1952 | United States |
| Helen DeVos Children's Hospital / Spectrum Health Medical Group | Wyoming | Michigan | 49418 | United States |
| St. Charles Psychiatric Associates dba Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Movement Disorders Center | St Louis | Missouri | 63110-1093 | United States |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | United States |
| Center for Psychiatry and Behavioral Medicine Inc. | Las Vegas | Nevada | 89128 | United States |
| The NeuroCognitive Institute | Mount Arlington | New Jersey | 07856 | United States |
| Clinical Research Center of NJ | Voorhees Township | New Jersey | 08043-1910 | United States |
| New York Neurology Associates P.C | New York | New York | 10003 | United States |
| Hapworth Research Inc. | New York | New York | 10019 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029-6504 | United States |
| Mood Disorders Consulting Medicine PLLC | New York | New York | 10036 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Quest Therapeutics of Avon Lake | Avon Lake | Ohio | 44012-1004 | United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229-3026 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| North Star Medical Research LLC | Middleburg Heights | Ohio | 44130 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| Access Clinical Trials, Inc. | Nashville | Tennessee | 37203-6502 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-0028 | United States |
| Houston Clinical Trials LLC | Bellaire | Texas | 77401 | United States |
| Relaro Medical Trials | Dallas | Texas | 75243 | United States |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Road Runner Research Ltd. | San Antonio | Texas | 78249-3539 | United States |
| Noetic Psychiatry | Springville | Utah | 84663 | United States |
| University of Virginia | Charlottesville | Virginia | 22908-0829 | United States |
| Eastside Therapeutic Resource Inc dba Core Clinical Research | Everett | Washington | 98201-4077 | United States |
| The Kids Clinic Inc | Ajax | Ontario | L1Z 0M1 | Canada |
| Center for Pediatric Excellence | Ottawa | Ontario | K2G 1W2 | Canada |
| CHU Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| CHU Poitiers | Poitiers | 86021 | France |
| Pharmakologisches Studienzentrum Chemnitz GmbH | Mittweida | 09648 | Germany |
| Gdanskie Centrum Zdrowia Sp z o.o. | Gdansk | 80-542 | Poland |
| Centrum Bada Klinicznych PI-House Sp. z o.o. | Gdansk | 80-546 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis | Katowice | 40-123 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie | Krakow | 31-503 | Poland |
| Med-Polonia Sp. z o. o. | Poznan | 60-693 | Poland |
| Safety Set (Treated) | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. |
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| Modified Intention-to-Treat Set | The Modified Intention-to-Treat (mITT) set included all participants who received at least one dose of study drug and had at least one post Baseline scoring of Yale Global Tic Severity Scale (YGTSS). |
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| COMPLETED |
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| NOT COMPLETED |
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The mITT set included all participants who received at least one dose of study drug and had at least one post baseline scoring of YGTSS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ecopipam HCI 2 mg/kg/Day | Participants received ecopipam HCl tablets at a targeted dose of 2 mg/kg/day, orally, once daily for up to 52 weeks. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | An AE was any untoward medical condition that occurs in a participant while participating in this clinical study. It can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. The relationship of the study drug in causing or contributing to the AE whether unrelated, possibly related, or probably related was decided by investigator medical judgment. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. | Posted | Count of Participants | Participants | From start of study drug administration until 30 days after last dose (Up to Month 13) |
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| Primary | Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Basophils/Leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in basophils to leukocytes ratio is reported in terms of percentage of cells. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of cells | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Eosinophils/Leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in eosinophils to leukocytes ratio is reported in terms of percentage of cells. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of cells | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Erythrocytes | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter erythrocytes was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Hematocrit | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter hematocrit was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | liter of cells per liter of blood (L/L) | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Hemoglobin | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameter hemoglobin was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimoles per liter (mmoL/L) | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Leukocytes and Platelets | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in hematology parameters (Leukocytes and Platelets) expressed in 10^9 cells per liter were reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 10^9 cells per liter | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Lymphocytes/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in lymphocytes to leukocytes ratio is reported in terms of percentage of cells. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of cells | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Monocytes/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in monocytes to leukocytes ratio is reported in terms of percentage of cells. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of cells | Baseline up to Month 12 |
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| Primary | Change From Baseline in Hematology Parameters: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Neutrophils/leukocytes was measured in percentages (%). Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in neutrophils to leukocytes ratio is reported in terms of percentage of cells. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of cells | Baseline up to Month 12 |
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| Primary | Change From Baseline in Serum Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Lactase Dehydrogenase | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, and lactate dehydrogenase) were reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at the specified categories. | Posted | Mean | Standard Deviation | units per liter (U/L) | Baseline up to Month 12 |
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| Primary | Change From Baseline in Serum Chemistry Parameters: Albumin, Globulin and Protein | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (albumin, globulin and protein) were reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline up to Month 12 |
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| Primary | Change From Baseline in Serum Chemistry Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglyceride and Urea Nitrogen | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (bicarbonate, calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglyceride, urea nitrogen) expressed in millimoles per liter (mmol/L) were reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Baseline up to Month 12 |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Serum Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in Serum chemistry parameters (bilirubin, creatinine and direct bilirubin) expressed in micromole per liter (mcmol/L) were reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at the specified categories. | Posted | Mean | Standard Deviation | mcmol/L | Baseline up to Month 12 |
|
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| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in HbA1c was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Vital Signs Parameter: Diastolic Blood Pressure and Systolic Blood Pressure | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs parameters diastolic blood pressure and systolic blood pressure and according to the assessment position (supine and standing) expressed in millimeter(s) of mercury (mmHg) was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at the specified categories. | Posted | Mean | Standard Deviation | mmHg | Baseline up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Vital Signs Parameter: Pulse Rate | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital sign parameter pulse rate and according to assessment position (supine and standing) was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at the specified categories. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Vital Signs Parameter: Body Mass Index [BMI] | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs parameter BMI was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | kilograms per square meter (kg/m^2) | Baseline up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Vital Signs Parameter: Height | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs height was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | centimeter (cm) | Baseline up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Vital Signs Parameter: Weight | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change from baseline in vital signs parameter weight was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Electrocardiogram (ECG) Values Parameters: Aggregate PR Interval, Aggregate QRS Duration, Aggregate QT Interval, and Aggregate QTc Interval | Baseline was defined as the last measurement taken before the first dose of open-label treatment on Day 1 of current study. Change From Baseline in ECG parameters aggregate PR interval, aggregate QRS duration, aggregate QT interval, and aggregate QTc interval expressed in millisecond (msec) was reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millisecond (msec) | Baseline to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Physical examination included examination of the following body areas and systems: Head, Eyes, Ears, Nose, Mouth, Throat, Neck (including Thyroid), Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae and Others. Any clinically significant abnormalities in physical examination were judged by the investigator. Only non-zero values are reported. | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at the specified categories. | Posted | Count of Participants | Participants | Baseline up to Month 12 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Yale Global Tic Severity Scale -Total Tic Score (YGTSS-TTS) at Months 1, 3, 6, 9 and 12 | The YGTSS was a clinician-completed rating scale used to quantify overall tic severity as well as specific subdomains of tic number, frequency, intensity, complexity and interference. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a total tic score ranging from 0 to 50. Higher scores represent more severe symptoms. A negative change from baseline indicates improvement. | The mITT set included all participants who received at least one dose of study drug and had at least one post Baseline scoring of YGTSS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Months 1, 3, 6, 9 and 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Yale Global Tic Severity Scale - Impairment (YGTSS-I) at Months 1, 3, 6, 9 and 12 | The YGTSS was a clinician-completed rating scale used to quantify overall tic severity as well as specific subdomains of tic number, frequency, duration, intensity, and complexity. Each of these subdomains was scored, on 0 to 5 scale, separately for an overall impairment rating from (0 = ''none'' to 50 = ''severe''). Higher score represent more severe symptoms. A negative change from baseline indicates improvement. | The mITT set included all participants who received at least one dose of study drug and had at least one post Baseline scoring of YGTSS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Months 1, 3, 6, 9 and 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Yale Global Tic Severity Scale - Global Score (YGTSS-GS) at Months 1, 3, 6, 9 and 12 | The YGTSS was a clinician-completed rating scale used to quantify overall tic severity as well as specific subdomains of tic number, frequency, duration, intensity, and complexity. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a tic severity score ranging from 0 to 50. The YGTSS also provides for an overall impairment rating (0 = ''none'' to 50 = ''severe''). YGTSS-GS is the total of YGTSS-TTS and YGTSS-I. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics. A negative change from baseline indicates improvement. | The mITT set included all participants who received at least one dose of study drug and had at least one post Baseline scoring of YGTSS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Months 1, 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression of Tourette Syndrome of Severity (CGI-TS-S) at Months 1, 3, 6, 9, 12 | The CGI consists of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The CGI severity scale (CGI-TS-S) ranges from 1 = "not ill at all" to 7 = "among the most extremely ill." Higher scores represent more severe symptoms. A negative change from baseline indicates improvement. | The mITT set included all participants who received at least one dose of study drug and had at least one post Baseline scoring of YGTSS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Months 1, 3, 6, 9, 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression Tourette Syndrome of Improvement (CGI-TS-I) Scores at Months 1, 3, 6, 9 and 12 | The CGI consists of 2 reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The scale ranges from 1 = "very much improved" to 7 = very much worse" for the CGI-TS-I. Higher score represent more severe symptoms. | The mITT set included all participants who received at least one dose of study drug and had at least one post Baseline scoring of YGTSS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Months 1, 3, 6, 9 and 12 |
|
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| Secondary | Change From Baseline in Gilles de la Tourette Syndrome-Quality of Life Scale for Children and Adolescents (C&A-GTS-QOL) Total Score at Months 1, 3, 6, 9 and 12 | The C&A-GTS-QOL was a 27-item questionnaire specific to TS patients that asks the patient to assess the extent to which their quality of life is impacted by their symptoms. The C&A-GTS-QOL consists of 6 subscales (cognitive [score range 0-32], coprophenomena [range 0-12], psychological [range 0-24], physical [range 0-12], obsessive-compulsive [range 0-16], and activities of daily living (ADL) [range 0-12] and uses a 5 point Likert scale ranging from no problem to extreme problem. Scores for six subscales were generated by summing items and, for ease of interpretation, transformation to a range of 0 to 100 (100* [(observed score-min possible score)/(max possible score-min possible score)]). Total score, resulted from sum of the subscale scores, was also normalized to a 0 to 100 range. Higher score indicated worst quality of life. A negative change from baseline indicates better quality of life. | The mITT set included all participants who received at least one dose of study drug and had at least one post Baseline scoring of YGTSS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Months 1, 3, 6, 9 and 12 |
|
From Baseline up to 30 days after last dose of the study drug (Up to Month 13)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ecopipam HCI 2 mg/kg/Day | Participants received ecopipam HCl tablets at a targeted dose of 2 mg/kg/day, orally, once daily for up to 52 weeks. | 0 | 121 | 2 | 121 | 84 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Obsessive thoughts | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tourette's disorder | Congenital, familial and genetic disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tooth resorption | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Adenoiditis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Penis injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Testicular injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Formication | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Narcolepsy | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Postural tremor | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tongue biting | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dissociative disorder | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Compulsions | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Social anxiety disorder | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Terminal insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vein collapse | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
PI must consult their clinical trial agreement. In summary, PI shall have the right to publish, present or otherwise use the results for their research publication objectives, provided that such Publication does not disclose Confidential Information. PI shall submit in writing to Sponsor any material at least 90 days for review and comment. Sponsor shall advise PI of any information which is Confidential Information or which may impair Sponsor's ability to obtain patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director of Clinical Operations | Emalex Biosciences, Inc. | 1847 | 7150562 | dkim@emalexbiosciences.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2023 | Nov 9, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C058081 | ecopipam |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Poland |
|
| Title | Measurements |
|---|---|
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| Participants with possibly related AEs |
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| Participants with probably related AEs |
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| Participants with unrelated SAEs |
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| Participants with possibly related SAEs |
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| Participants with probably related SAEs |
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