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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001891-73 | EudraCT Number |
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The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.
Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SD-809 | Experimental | Participants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158. |
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| Part B: Placebo | Placebo Comparator | Participants will receive placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter will receive SD-809 (stable dose) for 12 weeks. |
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| Part B: SD-809 | Active Comparator | Participants will receive SD-809 (stable dose) for 1 week in randomized withdrawal period and will continue to receive the same dose of SD-809 for an additional 12 weeks. |
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| Part C: SD-809 | Experimental | EU participants who complete Part B and willing to continue in the study will continue treatment with SD-809 for 52 weeks at the dose administered during the 12-week open-label period of Part B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SD-809 | Drug | SD-809 will be administered per dose and schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days) |
| Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | Day 1 of Part B, Day 7 of Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, M.D. | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 145 | Tuscaloosa | Alabama | 35404 | United States | ||
| Teva Investigational Site 107 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38557959 | Derived | Frank S, Anderson KE, Fernandez HH, Hauser RA, Claassen DO, Stamler D, Factor SA, Jimenez-Shahed J, Barkay H, Wilhelm A, Alexander JK, Chaijale N, Barash S, Savola JM, Gordon MF, Chen M. Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease. Neurol Ther. 2024 Jun;13(3):655-675. doi: 10.1007/s40120-024-00600-1. Epub 2024 Apr 1. | |
| 31296586 |
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Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)
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Study included 3 parts: A, B, and C. Participants in Part A who were on a stable dose for ≥4 weeks after a 6-week titration, were invited to participate in Part B. Participants who are noted as "Completed" for Part A: completed the study in Part A plus continued in Part B. EU participants who completed Part B were invited to participate in Part C.
343 participants who completed previous SD-809 studies, including study SD-809-C-18 (NCT02195700) or SD-809-C-23 (NCT02291861) were enrolled and 337 participants were eligible for analysis. 6 participants were not evaluable and were excluded from the analysis due to site data integrity issues as reported to the United States Food and Drug Administration (US FDA).
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| ID | Title | Description |
|---|---|---|
| FG000 | SD-809 | Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A: Open-Label (158 Weeks) |
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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 | May 2, 2018 | Nov 30, 2020 |
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| Placebo | Drug | Placebo matching to SD-809 will be administered per schedule specified in the arm. |
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| Baseline, Week 145 |
| Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | Baseline, Week 158 |
| Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | Baseline, Week 145 |
| Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | Baseline, Week 158 |
| Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | Baseline to Week 145 |
| Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | Baseline to Week 145 |
| Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease. | Baseline, Week 145 |
| Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC) | A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy. | Baseline up to Week 145 |
| Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC) | A treatment success was defined as much or very much improved on the PGIC from baseline of this study. The PGIC is single-item questionnaire that asks the participant to assess their TD symptoms at specific visits/weeks after initiating therapy. The PGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy. | Baseline up to Week 145 |
| Part A: Change From Baseline in Modified CDQ-24 Score at Week 158 | The CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ-24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains were evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment. | Baseline, Week 158 |
| Anaheim |
| California |
| 92804 |
| United States |
| Teva Investigational Site 108 | Anaheim | California | 92805 | United States |
| Teva Investigational Site 123 | Glendale | California | 91206 | United States |
| Teva Investigational Site 160 | Irvine | California | 92614 | United States |
| Teva Investigational Site 176 | Loma Linda | California | 92354 | United States |
| Teva Investigational Site 121 | Los Angeles | California | 90033 | United States |
| Teva Investigational Site 147 | Los Angeles | California | 90095-1769 | United States |
| Teva Investigational Site 174 | Norwalk | California | 90650 | United States |
| Teva Investigational Site 130 | Oceanside | California | 92056 | United States |
| Teva Investigational Site 102 | Orange | California | 92868 | United States |
| Teva Investigational Site 104 | San Bernardino | California | 92408 | United States |
| Teva Investigational Site 110 | San Diego | California | 92108 | United States |
| Teva Investigational Site 169 | San Rafael | California | 94901 | United States |
| Teva Investigational Site 129 | Englewood | Colorado | 80113 | United States |
| Teva Investigational Site 139 | New Haven | Connecticut | 06519 | United States |
| Teva Investigational Site 156 | Washington D.C. | District of Columbia | 20007 | United States |
| Teva Investigational Site 157 | Boca Raton | Florida | 33486 | United States |
| Teva Investigational Site 117 | Gainesville | Florida | 32607 | United States |
| Teva Investigational Site 150 | Lake City | Florida | 32025 | United States |
| Teva Investigational Site 153 | Miami | Florida | 33135 | United States |
| Teva Investigational Site 162 | Miami | Florida | 33165 | United States |
| Teva Investigational Site 112 | Orlando | Florida | 32803 | United States |
| Teva Investigational Site 144 | Port Charlotte | Florida | 33980 | United States |
| Teva Investigational Site 155 | Augusta | Georgia | 30912 | United States |
| Teva Investigational Site 165 | Decatur | Georgia | 30033 | United States |
| Teva Investigational Site 131 | Chicago | Illinois | 60611 | United States |
| Teva Investigational Site 154 | Baltimore | Maryland | 21287 | United States |
| Teva Investigational Site 101 | Glen Burnie | Maryland | 21061 | United States |
| Teva Investigational Site 118 | Creve Coeur | Missouri | 63141 | United States |
| Teva Investigational Site 142 | Kansas City | Missouri | 64108 | United States |
| Teva Investigational Site 175 | St Louis | Missouri | 63104 | United States |
| Teva Investigational Site 161 | St Louis | Missouri | 63109 | United States |
| Teva Investigational Site 178 | Lincoln | Nebraska | 68526-9467 | United States |
| Teva Investigational Site 128 | Albuquerque | New Mexico | 87106 | United States |
| Teva Investigational Site 146 | Raleigh | North Carolina | 27610 | United States |
| Teva Investigational Site 114 | Garfield Heights | Ohio | 44125 | United States |
| Teva Investigational Site 133 | Charleston | South Carolina | 29425 | United States |
| Teva Investigational Site 149 | Memphis | Tennessee | 38163 | United States |
| Teva Investigational Site 151 | Fort Worth | Texas | 76104 | United States |
| Teva Investigational Site 115 | Salt Lake City | Utah | 84105 | United States |
| Teva Investigational Site 141 | Salt Lake City | Utah | 84108 | United States |
| Teva Investigational Site 167 | Richland | Washington | 99352 | United States |
| Teva Investigational Site 166 | Waukesha | Wisconsin | 53188 | United States |
| Teva Investigational Site 559 | Havířov | 736 01 | Czechia |
| Teva Investigational Site 556 | Hostivice | 999999 | Czechia |
| Teva Investigational Site 535 | Litoměřice | 412 01 | Czechia |
| Teva Investigational Site 557 | Pilsen | 312 00 | Czechia |
| Teva Investigational Site 533 | Prague | 100 00 | Czechia |
| Teva Investigational Site 530 | Prague | 16000 | Czechia |
| Teva Investigational Site 502 | Gera | 07551 | Germany |
| Teva Investigational Site 504 | Mainz | 55131 | Germany |
| Teva Investigational Site 540 | Balassagyarmat | 999999 | Hungary |
| Teva Investigational Site 538 | Budapest | 1135 | Hungary |
| Teva Investigational Site 541 | Budapest | 1148 | Hungary |
| Teva Investigational Site 539 | Doba | 8482 | Hungary |
| Teva Investigational Site 546 | Győr | H-9024 | Hungary |
| Teva Investigational Site 545 | Kalocsa | 6300 | Hungary |
| Teva Investigational Site 514 | Bełchatów | 97-400 | Poland |
| Teva Investigational Site 554 | Bialystok | 15-756 | Poland |
| Teva Investigational Site 510 | Bydgoszcz | 85-015 | Poland |
| Teva Investigational Site 519 | Bydgoszcz | 85-080 | Poland |
| Teva Investigational Site 536 | Bydgoszcz | 85-156 | Poland |
| Teva Investigational Site 523 | Chełmno | 86-200 | Poland |
| Teva Investigational Site 517 | Choroszcz | 16-070 | Poland |
| Teva Investigational Site 513 | Gdansk | 80-952 | Poland |
| Teva Investigational Site 512 | Katowice | 40-097 | Poland |
| Teva Investigational Site 552 | Katowice | 40-123 | Poland |
| Teva Investigational Site 520 | Krakow | 30-349 | Poland |
| Teva Investigational Site 509 | Krakow | 31-505 | Poland |
| Teva Investigational Site 508 | Lodz | 90-130 | Poland |
| Teva Investigational Site 511 | Lublin | 20-064 | Poland |
| Teva Investigational Site 524 | Lublin | 20-831 | Poland |
| Teva Investigational Site 549 | Olsztyn | 10-443 | Poland |
| Teva Investigational Site 522 | Torun | 87-100 | Poland |
| Teva Investigational Site 550 | Warsaw | 00-465 | Poland |
| Teva Investigational Site 516 | Wroclaw | 50-227 | Poland |
| Teva Investigational Site 529 | Bratislava | 826 06 | Slovakia |
| Teva Investigational Site 525 | Domaša | 935 61 | Slovakia |
| Teva Investigational Site 527 | Košice | 04017 | Slovakia |
| Teva Investigational Site 528 | Rimavská Sobota | 979 12 | Slovakia |
| Teva Investigational Site 526 | Rožňava | 04801 | Slovakia |
| Derived |
| Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323. doi: 10.1136/jnnp-2018-319918. Epub 2019 Jul 10. |
| Part B: Placebo |
Participants received placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks. |
| FG002 | Part B: SD-809 | Participants received SD-809 (stable dose) for 1 week in randomized withdrawal period and continued to receive the same dose of SD-809 for an additional 12 weeks. |
| FG003 | Part C: SD-809 | EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B. |
| Received at Least 1 Dose of Study Drug |
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| Intent-to-Treat (ITT) Population | All participants who enrolled in the study, regardless of whether or not received study drug. |
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| Participants Who Participated in Part A But Not in Part B |
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| Participants Who Agreed to Continue in Part B |
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| COMPLETED | Participants who are noted as "Completed" for Part A: completed the study in Part A (Week 158) plus continued in Part B. |
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| NOT COMPLETED |
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| Part B: Randomized (13 Weeks) |
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| Part C: Safety Assessment (52 Weeks) |
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ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SD-809 | Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158. |
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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/Ethnicity, Customized | Count of Participants | Participants |
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| Total Motor Abnormal Involuntary Movement Scale (AIMS) Score | AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| AIMS Individual Items (8-10) Scores | AIMS is composed of 12 clinician-administered and -scored items. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Modified Craniocervical Dystonia Questionnaire 24 (CDQ-24) Score | CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants with craniocervical dystonia. CDQ-24 was modified such that the questions focus more directly on the impact of TD on quality of life. The following domains were evaluated in mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment. | Mean | Standard Deviation | units on a scale |
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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 | Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal | AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who were administered any study drug. | Posted | Count of Participants | Participants | Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days) |
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| Primary | Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | The randomized withdrawal modified intent-to-treat (mITT) population included all participants enrolled in Part B who received study drug during the randomized withdrawal period and had a total motor AIMS score as assessed by blinded central video rating at both the pre-withdrawal visit and the post-withdrawal visit. | Posted | Mean | Standard Error | units on a scale | Day 1 of Part B, Day 7 of Part B |
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| Secondary | Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 145 |
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| Secondary | Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 158 |
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| Secondary | Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Error | percent change | Baseline, Week 145 |
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| Secondary | Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Error | percent change | Baseline, Week 158 |
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| Secondary | Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline to Week 145 |
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| Secondary | Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline to Week 145 |
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| Secondary | Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating | The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and -scored items. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 145 |
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| Secondary | Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC) | A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 145 |
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| Secondary | Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC) | A treatment success was defined as much or very much improved on the PGIC from baseline of this study. The PGIC is single-item questionnaire that asks the participant to assess their TD symptoms at specific visits/weeks after initiating therapy. The PGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 145 |
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| Secondary | Part A: Change From Baseline in Modified CDQ-24 Score at Week 158 | The CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ-24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains were evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment. | The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 158 |
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|
Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)
Adverse events were analyzed as one group combined for Parts A and B and as a separate group for Part C per planned analysis.
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 | Part A and Part B Participants | Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158. Participants who agreed to participate in Part B, received SD-809 or placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks. | 8 | 337 | 68 | 337 | 172 | 337 |
| EG001 | Part C: SD-809 | EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B. | 2 | 80 | 5 | 80 | 5 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancreatic duct stenosis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Generalised non-convulsive epilepsy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypomania | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products R&D, Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2019 | Nov 30, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000071057 | Tardive Dyskinesia |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D004409 | Dyskinesia, Drug-Induced |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609690 | deutetrabenazine |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Adverse Event |
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| Death |
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| Unknown or Not Reported |
|
| Black |
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| White |
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| Other |
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| Participant's awareness of abnormal movements |
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| Severe TEAEs |
|
| Drug-Related TEAEs |
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| TEAEs Leading to Withdrawal From Study |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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