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This is a Phase IV, prospective, observational, post-marketing study designed to obtain additional data on the effect of XADAGO on motor and non-motor symptoms in Parkinson's Disease patients newly prescribed XADAGO.
This Phase IV, multicenter, prospective, observational study to evaluate clinician-reported outcomes and patient-reported outcomes related to motor and non-motor symptoms, health status, quality of life and treatment satisfaction in PD patients who have been newly prescribed XADAGO according to Package Insert indication.
This study also will gather "real world" data from a PD population in the US regarding their overall experience and degree of satisfaction with the use of XADAGO as an add-on treatment to their L-dopa regimen. Treatment experience will be captured using patient self-rating assessments as well as clinician ratings on assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease Patients | PD patients who have been newly prescribed safinamide (XADAGO) for the treatment of OFF episodes as described in the XADAGO Package Insert |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XADAGO (safinamide) | Drug | XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score. | Baseline to Study Day 60 |
| Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores | PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes. | Baseline to Study Day 60 |
| Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score. | MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances. | Baseline to Study Day 60 |
| Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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Parkinson's Disease patients who have been newly prescribed XADAGO
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| Name | Affiliation | Role |
|---|---|---|
| Najeebah Abdul-Musawir, MD,MBA | Supernus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Neurology Associates | Homewood | Alabama | 35244 | United States | ||
| Movement Disorders Neurology, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DA Switchers | Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA) |
| FG001 | MAO-B Switchers | Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| 2 Month Study Completion |
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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 | Oct 12, 2018 | Nov 25, 2020 |
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| Study Day 60 |
| Clinical Global Impression of Change (CGI-C) | CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse). | Study Day 60 |
| Patient Global Impression of Change (PGI-C) | PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse). | Study Day 60 |
| Bakersfield |
| California |
| 93312 |
| United States |
| B.E.S.T. Center of Orange County | Laguna Hills | California | 92653 | United States |
| Valley Parkinson Clinic | Los Gatos | California | 95032 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Hartford Healthcare | Vernon | Connecticut | 06066 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Neuron Research | Naples | Florida | 34108 | United States |
| Parkinson's Disease Treatment Center of SW Florida | Port Charlotte | Florida | 33980 | United States |
| Sarasota Memorial Hospital Clinical Research Cener | Sarasota | Florida | 34239 | United States |
| Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Baptist Health System | Richmond | Kentucky | 40475 | United States |
| Southeast Neuroscience Center, LLC | Gray | Louisiana | 70359 | United States |
| Lester and Cox Medical Center | Springfield | Missouri | 65807 | United States |
| Neurological Associates of Long Island, PC | Lake Success | New York | 11042 | United States |
| NYU Winthrop Hospital | Mineola | New York | 11501 | United States |
| FryeCare Neurology | Hickory | North Carolina | 28602 | United States |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | United States |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74137 | United States |
| Neurology and Stroke Associates | Lititz | Pennsylvania | 17543 | United States |
| Prisma Health | Greenville | South Carolina | 29615 | United States |
| Covenant Medical Group | Lubbock | Texas | 79410 | United States |
| Texas Institute for Neurological Disorders | Sherman | Texas | 75092 | United States |
| Houston Methodist - Sugar Land | Sugar Land | Texas | 77479 | United States |
| Baylor Scott and White Health | Temple | Texas | 76508 | United States |
| Inova Medical Group- Neurology I | Alexandria | Virginia | 22311 | United States |
| Meridian Clinical Research, LLC | Norfolk | Virginia | 23502 | United States |
| Puget Sound Neurology | Tacoma | Washington | 98409 | United States |
| FG002 | MAO-B Naive | Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve. |
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| COMPLETED |
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| NOT COMPLETED |
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| 4 Month Study Optional Extension |
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Safety Population: All patients who sign informed consent for the study, complete baseline assessments, and receive at least 1 dose of XADAGO.
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| ID | Title | Description |
|---|---|---|
| BG000 | DA Switchers | Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA) |
| BG001 | MAO-B | Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor |
| BG002 | MAO-B Naive | Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| Age, Customized | Count of Participants | Participants |
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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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| Height (cm) | Mean | Standard Deviation | cm |
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| Weight (kg) | Mean | Standard Deviation | kg |
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| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Movement Disorders Society - Unified Parkinson's Disease Rating Scale | MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score. | Evaluable Population: All patients in the safety population who complete at least the Movement Disorders Society - Unified Parkinson's Disease Rating Scale assessment at the Study Day 60 visit | 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 Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | MDS-UPDRS: 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items; Score 0-52) examines non-motor experiences, Part II (13 items; Score 0-52) examines motor experiences, Part III (33 items; Score 0-132) examines the cardinal motor disabilities and Part IV (6 items; Score 0-24) examines motor complications. Each Part has 0-4 ratings, where 0 (no problems) to 4 (severe problems) and scores for each part are summed to calculate the total score which ranges from 0-260. Higher scores represent worse outcomes for each part and total score. | Overall Number of Participants Analyzed represented by initial number analyzed at study visit Day 60; Number may differ for each Part (1-4) due to availability of score data. Evaluable Population: all subjects in the safety population who complete at least the MDS-UPDRS assessment at the Study Day 60 visit. Evaluable population will be used to analyze MDS-UPDRS endpoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Study Day 60 |
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| Primary | Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores | PDQ-39 is a patient-reported outcome designed to address aspects of functioning and well-being for those affected by PD. Each of the 39 items is rated using a 5 point Likert scale with 0 for never having difficulties/problems and 4 for always having difficulties/problems. The sum score of the 39 items will be calculated and used for analysis, with scores ranging from 0-156. Higher scores indicate worse outcomes. | Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Study Day 60 |
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| Primary | Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score. | MoCA is a 30-point, 1-page test designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). The total score ranges from 0 to 30, with higher scores indicating better performances. | Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Study Day 60 |
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| Primary | Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions will be calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction. | Overall Number of Participants Analyzed represented by number analyzed at study visit Day 60. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS. | Posted | Mean | Standard Deviation | score on a scale | Study Day 60 |
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| Primary | Clinical Global Impression of Change (CGI-C) | CGI-C is a 7-point scale depicting a Principal Investigator or certified Health Care Professional designee rating of the patient's overall improvement using a range of responses from a minimum of 1 (very much improved) to a maximum of 7 (very much worse). | Posted | Count of Participants | Participants | Study Day 60 |
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| Primary | Patient Global Impression of Change (PGI-C) | PGI-C is a 7-point scale depicting a patient's rating of overall improvement using a range of responses from 1 (very much improved) to 7 (very much worse). | Participants Analyzed does not match the Participant Flow because some patient data was not captured for the visit. Safety Population: all subjects who sign informed consent form, complete baseline assessments, receive at least 1 dose of XADAGO. Safety population used to analyze all efficacy endpoints except MDS-UPDRS. | Posted | Count of Participants | Participants | Study Day 60 |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DA Switchers | Parkinson's Disease patients that have switched to safinamide (XADAGO) from a dopamine agonist (DA) | 0 | 2 | 0 | 2 | 1 | 2 |
| EG001 | MAO-B Switchers | Parkinson's Disease patients that have switched to safinamide (XADAGO) from a monoamine oxidase-B (MAO-B) inhibitor | 0 | 34 | 2 | 34 | 8 | 34 |
| EG002 | MAO-B Naive | Parkinson's Disease patients taking safinamide (XADAGO) that are MAO-B inhibitor naïve. | 2 | 128 | 8 | 128 | 17 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Postoperataive ileus | Gastrointestinal disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pneumothorax traumatic | Injury, poisoning and procedural complications | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Traumatic haemothorax | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysarthria | Nervous system disorders | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gianpiera Ceresoli-Borroni | Supernus Pharmacueticals | 301-838-2521 | gceresoliborroni@supernus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2020 | Nov 25, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C092797 | safinamide |
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