Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
- Registration Number
- NCT03944785
- Lead Sponsor
- Supernus Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- Patient (and Care Partner, if required per Inclusion Criterion 6) is able to understand and provide signed informed consent and HIPAA authorization in English.
- Patient with diagnosis of idiopathic PD (all stages).
- Independent of the study, clinician's and patient's choice of treatment is XADAGO in accordance with the Package Insert indication.
- 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.
- Patient has access to an electronic device for the interim completion of PROs.
- 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.
- 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.).
- 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.
- 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.
- 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).
- Severe or unpredictable dyskinesia at the time of the Baseline Visit.
- Previous participation in this study; a patient may not re-enroll after prior discontinuation or completion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson's Disease Patients XADAGO (safinamide) PD patients who have been newly prescribed safinamide (XADAGO) for the treatment of OFF episodes as described in the XADAGO Package Insert
- Primary Outcome Measures
Name Time Method Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Baseline to Study Day 60 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.
Clinical Global Impression of Change (CGI-C) Study Day 60 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).
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores Baseline to Study Day 60 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.
Patient Global Impression of Change (PGI-C) Study Day 60 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).
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score. Baseline to Study Day 60 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.
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores Study Day 60 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Hartford Healthcare
🇺🇸Vernon, Connecticut, United States
Southeast Neuroscience Center, LLC
🇺🇸Gray, Louisiana, United States
NYU Winthrop Hospital
🇺🇸Mineola, New York, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Movement Disorders Neurology, Inc.
🇺🇸Bakersfield, California, United States
Valley Parkinson Clinic
🇺🇸Los Gatos, California, United States
Alabama Neurology Associates
🇺🇸Homewood, Alabama, United States
B.E.S.T. Center of Orange County
🇺🇸Laguna Hills, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Neuron Research
🇺🇸Naples, Florida, United States
Parkinson's Disease Treatment Center of SW Florida
🇺🇸Port Charlotte, Florida, United States
Sarasota Memorial Hospital Clinical Research Cener
🇺🇸Sarasota, Florida, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Baptist Health System
🇺🇸Richmond, Kentucky, United States
Neurological Associates of Long Island, PC
🇺🇸Lake Success, New York, United States
FryeCare Neurology
🇺🇸Hickory, North Carolina, United States
Lester and Cox Medical Center
🇺🇸Springfield, Missouri, United States
Dayton Center for Neurological Disorders
🇺🇸Centerville, Ohio, United States
The Movement Disorder Clinic of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Neurology and Stroke Associates
🇺🇸Lititz, Pennsylvania, United States
Texas Institute for Neurological Disorders
🇺🇸Sherman, Texas, United States
Covenant Medical Group
🇺🇸Lubbock, Texas, United States
Baylor Scott and White Health
🇺🇸Temple, Texas, United States
Inova Medical Group- Neurology I
🇺🇸Alexandria, Virginia, United States
Puget Sound Neurology
🇺🇸Tacoma, Washington, United States
Meridian Clinical Research, LLC
🇺🇸Norfolk, Virginia, United States
Houston Methodist - Sugar Land
🇺🇸Sugar Land, Texas, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States