Idiopathic Parkinson Disease Clinical Trial
— PRO-GoOfficial title:
A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets
Verified date | July 2021 |
Source | Supernus Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 164 |
Est. completion date | January 10, 2020 |
Est. primary completion date | December 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patient (and Care Partner, if required per Inclusion Criterion 6) is able to understand and provide signed informed consent and HIPAA authorization in English. 2. Patient with diagnosis of idiopathic PD (all stages). 3. Independent of the study, clinician's and patient's choice of treatment is XADAGO in accordance with the Package Insert indication. 4. Patient is willing and able to participate in the study and complete study-related assessments for 2 months and, patients can continue for an optional 4-month study extension. 5. Patient has access to an electronic device for the interim completion of PROs. 6. Patient has an available Care Partner who is able and willing to assist with clinic attendance and completion of study assessments (e.g., PROs, health outcomes, etc.), if in the PI's opinion, assistance is needed to comply with all study visits and procedures. Exclusion Criteria: 1. Any of the warnings, precautions, or contraindications listed in the XADAGO Package Insert that in the opinion of the PI would prevent appropriate treatment with XADAGO or impair study participation (e.g., pregnancy, lactation, severe hepatic impairment, etc.). 2. Participation in any other clinical trial of an investigational drug or device within 4 weeks prior to the Baseline Visit or at any time during the study. 3. Patient is currently receiving chemotherapy or radiation for any form of cancer (if history of cancer, must be in clinical remission at study entry) or currently receiving immunotherapy. 4. Patients with conditions that are likely to prevent them from accurately and reliably completing study assessments, including evidence of moderate or severe dementia as determined by the clinician (not to include mild cognitive impairment [MCI]); major psychiatric illness (specifically diagnosis of schizophrenia, bipolar disorder or a history of attempted suicide); and/or severe and progressive medical illness (including terminal cancer, end-stage renal disease +/- undergoing dialysis). 5. Severe or unpredictable dyskinesia at the time of the Baseline Visit. 6. Previous participation in this study; a patient may not re-enroll after prior discontinuation or completion |
Country | Name | City | State |
---|---|---|---|
United States | Inova Medical Group- Neurology I | Alexandria | Virginia |
United States | Movement Disorders Neurology, Inc. | Bakersfield | California |
United States | Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida |
United States | Dayton Center for Neurological Disorders | Centerville | Ohio |
United States | Southeast Neuroscience Center, LLC | Gray | Louisiana |
United States | Prisma Health | Greenville | South Carolina |
United States | FryeCare Neurology | Hickory | North Carolina |
United States | Alabama Neurology Associates | Homewood | Alabama |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | B.E.S.T. Center of Orange County | Laguna Hills | California |
United States | Neurological Associates of Long Island, PC | Lake Success | New York |
United States | Neurology and Stroke Associates | Lititz | Pennsylvania |
United States | Valley Parkinson Clinic | Los Gatos | California |
United States | Covenant Medical Group | Lubbock | Texas |
United States | NYU Winthrop Hospital | Mineola | New York |
United States | Neuron Research | Naples | Florida |
United States | Meridian Clinical Research, LLC | Norfolk | Virginia |
United States | Parkinson's Disease Treatment Center of SW Florida | Port Charlotte | Florida |
United States | Baptist Health System | Richmond | Kentucky |
United States | UC Davis Medical Center | Sacramento | California |
United States | Sarasota Memorial Hospital Clinical Research Cener | Sarasota | Florida |
United States | Texas Institute for Neurological Disorders | Sherman | Texas |
United States | Lester and Cox Medical Center | Springfield | Missouri |
United States | Houston Methodist - Sugar Land | Sugar Land | Texas |
United States | Puget Sound Neurology | Tacoma | Washington |
United States | Baylor Scott and White Health | Temple | Texas |
United States | The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma |
United States | Hartford Healthcare | Vernon | Connecticut |
United States | Georgetown University Hospital | Washington | District of Columbia |
United States | Central DuPage Hospital | Winfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
Supernus Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Baseline to Study Day 60 | |
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. | Baseline to Study Day 60 | |
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. | Baseline to Study Day 60 | |
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. | Study Day 60 | |
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). | Study Day 60 | |
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). | Study Day 60 |
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