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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03944785
Other study ID # USWM-SA1-4001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2017
Est. completion date January 10, 2020

Study information

Verified date July 2021
Source Supernus Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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