Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)

Completed

Conditions studied: Idiopathic Parkinson Disease

In brief

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.

Key facts

Study ID

NCT03944785

Run by

Supernus Pharmaceuticals, Inc.

People needed

164

Starts

2017-11-30

Expected to finish

2020-01-10

Last updated by the study team

2023-06-07

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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