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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000622-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Nuvelution TS Pharma, Inc. | INDUSTRY |
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This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEV-50717 | Experimental | TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks |
|
| Placebo | Placebo Comparator | Placebo matched to TEV-50717 BID for a total of 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEV-50717 | Drug | 6, 9, 12, 15, and 18 mg oral tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the TTS of the YGTSS at Week 12 | YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12 | The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics). Lower scores indicate better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates. |
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Inclusion Criteria:
Participant is 6 to 16 years of age, inclusive.
Participant weighs at least 44 pounds (20 kilograms [kg]).
The participant's active tics are causing distress or impairment.
Participant is able to swallow study medication whole.
Participant is in good general health.
Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study.
Exclusion Criteria:
Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
Participant has clinically significant depression at screening or baseline.
Participant has a history of suicidal intent or related behaviors within 2 years of screening.
Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
Participant has a first-degree relative who has completed suicide.
Participant has received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
Participant has an unstable or serious medical illness at screening or baseline.
Participant is pregnant or breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 046-0104 | Dothan | Alabama | 36303 | United States | ||
| Teva Investigational Site 046-0117 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34609495 | Derived | Jankovic J, Coffey B, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander J, Barkay H, Harary E. Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128204. doi: 10.1001/jamanetworkopen.2021.28204. |
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A total of 119 participants were randomized in a 1:1 ratio to either TEV-50717 or placebo group.
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| ID | Title | Description |
|---|---|---|
| FG000 | TEV-50717 | Participants received TEV-50717 as oral tablets at a starting dose of 6 milligrams (mg)/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and cytochrome P450 2D6 (CYP2D6) impairment status at baseline. Maximum total daily dose for participants greater than or equal to (≥) 40 kilograms (kg) was 48 mg/day (24 mg twice daily [BID]), 30 to less than (<) 40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Titration Period (7 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 | Mar 25, 2019 | May 11, 2020 |
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| Placebo | Drug | Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks. |
|
| Baseline, Week 12 |
| Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12 | The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?). The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy. | Baseline, Week 12 |
| Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score at Week 12 | C&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms. C&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem. Following 3 questions from 27-item questionnaire were assessed in ADL C&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?). Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem). Lower score indicated better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6-11 years, 12-16 years) as covariates. | Baseline, Week 12 |
| Percentage of Participants With Adverse Events | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, 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 the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 1) to follow-up (Week 14) |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Teva Investigational Site 046-0107 | Rogers | Arkansas | 72758 | United States |
| Teva Investigational Site 046-0126 | Anaheim | California | 92805 | United States |
| Teva Investigational Site 046-0101 | Sacramento | California | 95815 | United States |
| Teva Investigational Site 046-0111 | San Diego | California | 92108 | United States |
| Teva Investigational Site 046-0130 | Santa Ana | California | 92705 | United States |
| Teva Investigational Site 046-0132 | Miami | Florida | 33155 | United States |
| Teva Investigational Site 046-0115 | Orlando | Florida | 32803 | United States |
| Teva Investigational Site 046-0114 | St. Petersburg | Florida | 33701 | United States |
| Teva Investigational Site 046-0116 | Atlanta | Georgia | 30331 | United States |
| Teva Investigational Site 046-0133 | Naperville | Illinois | 60563 | United States |
| Teva Investigational Site 046-0128 | Boston | Massachusetts | 02114 | United States |
| Teva Investigational Site 046-0110 | Saint Charles | Missouri | 63304 | United States |
| Teva Investigational Site 046-0134 | Lincoln | Nebraska | 68526-9467 | United States |
| Teva Investigational Site 046-0109 | Voorhees Township | New Jersey | 08043 | United States |
| Teva Investigational Site 046-0124 | New York | New York | 10029 | United States |
| Teva Investigational Site 046-0102 | Rochester | New York | 14618 | United States |
| Teva Investigational Site 046-0112 | Rochester | New York | 14642 | United States |
| Teva Investigational Site 046-0125 | Raleigh | North Carolina | 27607 | United States |
| Teva Investigational Site 046-0106 | Oklahoma City | Oklahoma | 73116 | United States |
| Teva Investigational Site 046-0113 | Dallas | Texas | 75243 | United States |
| Teva Investigational Site 046-0108 | Houston | Texas | 77030 | United States |
| Teva Investigational Site 046-0103 | Houston | Texas | 77090 | United States |
| Teva Investigational Site 046-0120 | San Antonio | Texas | 78249 | United States |
| Teva Investigational Site 046-0105 | Orem | Utah | 84058 | United States |
| Teva Investigational Site 046-0118 | Petersburg | Virginia | 23805 | United States |
| Teva Investigational Site 046-0201 | Ajax | Ontario | L1Z0M1 | Canada |
| Teva Investigational Site 046-0202 | Ottawa | Ontario | K2G 1W2 | Canada |
| Teva Investigational Site 046-0302 | Herlev | 2730 | Denmark |
| Teva Investigational Site 046-0301 | Odense | 5000 | Denmark |
| Teva Investigational Site 046-0702 | Stavropol | 355038 | Russia |
| Teva Investigational Site 046-0704 | Tomsk | 634050 | Russia |
| Teva Investigational Site 046-0703 | Voronezh | 394024 | Russia |
| Teva Investigational Site 046-1702 | Belgrade | 11000 | Serbia |
| Teva Investigational Site 046-1703 | Belgrade | 11000 | Serbia |
| Teva Investigational Site 046-1701 | Novi Sad | 21000 | Serbia |
| Teva Investigational Site 046-0604 | Barcelona | 08041 | Spain |
| Teva Investigational Site 046-0605 | Madrid | 28009 | Spain |
| Teva Investigational Site 046-0602 | Madrid | 28922 | Spain |
| Teva Investigational Site 046-0603 | Málaga | 29620 | Spain |
| Teva Investigational Site 046-0601 | Seville | 41013 | Spain |
| FG001 | Placebo | Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. |
|
| Safety Analysis Set | Received at least 1 dose of study drug |
|
| Modified ITT (mITT) Analysis Set | Received at least 1 dose of study drug; had both baseline & at least 1 postbaseline YGTSS assessment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Period (5 Weeks) |
|
|
ITT analysis set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TEV-50717 | Participants received TEV-50717 as oral tablets at a starting dose of 6 mg/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and CYP2D6 impairment status at baseline. Maximum total daily dose for participants ≥40 kg was 48 mg/day (24 mg BID), 30 to <40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks. |
| BG001 | Placebo | Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) | YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 for severe). Motor tic severity score (MTSS) is the sum of 5 items for motor tic severity and vocal tic severity score (VTSS) is the sum of 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. | Mean | Standard Deviation | units on a scale |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the TTS of the YGTSS at Week 12 | YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates. | mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12 | The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics). Lower scores indicate better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates. | mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12 | The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?). The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy. | mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score at Week 12 | C&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms. C&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem. Following 3 questions from 27-item questionnaire were assessed in ADL C&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?). Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem). Lower score indicated better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6-11 years, 12-16 years) as covariates. | mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, 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 the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline (Day 1) to follow-up (Week 14) |
|
Baseline (Day 1) to follow-up (Week 14)
Safety analysis set included all participants who received at least 1 dose of study drug.
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 | TEV-50717 | Participants received TEV-50717 as oral tablets at a starting dose of 6 mg/day, with the dose titrated weekly for 7 weeks to an optimal level. The target maximum daily dose was determined by body weight and CYP2D6 impairment status at baseline. Maximum total daily dose for participants ≥40 kg was 48 mg/day (24 mg BID), 30 to <40 kg was 42 mg/day (21 mg BID), and 20 to <30 kg was 30 mg/day (15 mg BID). For those considered CYP2D6 impaired, maximum daily dose for participants ≥40 kg was 36 mg/day, 30 to <40 kg was 24 mg/day, and 20 to <30 kg was 18 mg/day. Total daily doses of ≥12 mg/day was divided into a BID administration. Depending on the dose, TEV-50717 tablets and/or placebo tablets were taken to maintain the blind. Participants then received TEV-50717 at the optimal level as maintenance therapy daily for 5 weeks. | 0 | 58 | 0 | 58 | 22 | 58 |
| EG001 | Placebo | Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. | 0 | 59 | 0 | 59 | 23 | 59 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Enuresis | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 22.1 | 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 2, 2019 | May 11, 2020 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| C000609690 | deutetrabenazine |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| Native American |
|
| Multiple |
|
| Other |
|
| OG001 | Placebo | Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. |
|
|
Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. |
|
|
| OG001 | Placebo | Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. |
|
|
| OG001 | Placebo | Participants received placebo matched to TEV-50717 BID for a total of 12 weeks. |
|
|