Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
NCT ID: NCT03944785
Last Updated: 2023-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
164 participants
OBSERVATIONAL
2017-11-30
2020-01-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
XADAGO (safinamide)
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.
Interventions
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XADAGO (safinamide)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
80 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Najeebah Abdul-Musawir, MD,MBA
Role: STUDY_DIRECTOR
Supernus Pharmaceuticals, Inc.
Locations
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Alabama Neurology Associates
Homewood, Alabama, United States
Movement Disorders Neurology, Inc.
Bakersfield, California, United States
B.E.S.T. Center of Orange County
Laguna Hills, California, United States
Valley Parkinson Clinic
Los Gatos, California, United States
UC Davis Medical Center
Sacramento, California, United States
Hartford Healthcare
Vernon, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 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
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Health System
Richmond, Kentucky, United States
Southeast Neuroscience Center, LLC
Gray, Louisiana, United States
Lester and Cox Medical Center
Springfield, Missouri, United States
Neurological Associates of Long Island, PC
Lake Success, New York, United States
NYU Winthrop Hospital
Mineola, New York, United States
FryeCare Neurology
Hickory, North Carolina, 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
Prisma Health
Greenville, South Carolina, United States
Covenant Medical Group
Lubbock, Texas, United States
Texas Institute for Neurological Disorders
Sherman, Texas, United States
Houston Methodist - Sugar Land
Sugar Land, Texas, United States
Baylor Scott and White Health
Temple, Texas, United States
Inova Medical Group- Neurology I
Alexandria, Virginia, United States
Meridian Clinical Research, LLC
Norfolk, Virginia, United States
Puget Sound Neurology
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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USWM-SA1-4001
Identifier Type: -
Identifier Source: org_study_id
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