Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
PRO-Go
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
1 other identifier
observational
164
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2017
Typical duration for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2020
CompletedResults Posted
Study results publicly available
February 18, 2021
CompletedJune 7, 2023
July 1, 2021
2.1 years
May 1, 2019
November 25, 2020
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
Parkinson's Disease patients who have been newly prescribed XADAGO
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Alabama Neurology Associates
Homewood, Alabama, 35244, United States
Movement Disorders Neurology, Inc.
Bakersfield, California, 93312, United States
B.E.S.T. Center of Orange County
Laguna Hills, California, 92653, United States
Valley Parkinson Clinic
Los Gatos, California, 95032, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Hartford Healthcare
Vernon, Connecticut, 06066, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Neuron Research
Naples, Florida, 34108, United States
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida, 33980, United States
Sarasota Memorial Hospital Clinical Research Cener
Sarasota, Florida, 34239, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Baptist Health System
Richmond, Kentucky, 40475, United States
Southeast Neuroscience Center, LLC
Gray, Louisiana, 70359, United States
Lester and Cox Medical Center
Springfield, Missouri, 65807, United States
Neurological Associates of Long Island, PC
Lake Success, New York, 11042, United States
NYU Winthrop Hospital
Mineola, New York, 11501, United States
FryeCare Neurology
Hickory, North Carolina, 28602, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74137, United States
Neurology and Stroke Associates
Lititz, Pennsylvania, 17543, United States
Prisma Health
Greenville, South Carolina, 29615, United States
Covenant Medical Group
Lubbock, Texas, 79410, United States
Texas Institute for Neurological Disorders
Sherman, Texas, 75092, United States
Houston Methodist - Sugar Land
Sugar Land, Texas, 77479, United States
Baylor Scott and White Health
Temple, Texas, 76508, United States
Inova Medical Group- Neurology I
Alexandria, Virginia, 22311, United States
Meridian Clinical Research, LLC
Norfolk, Virginia, 23502, United States
Puget Sound Neurology
Tacoma, Washington, 98409, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gianpiera Ceresoli-Borroni
- Organization
- Supernus Pharmacueticals
Study Officials
- STUDY DIRECTOR
Najeebah Abdul-Musawir, MD,MBA
Supernus Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2019
First Posted
May 10, 2019
Study Start
November 30, 2017
Primary Completion
December 23, 2019
Study Completion
January 10, 2020
Last Updated
June 7, 2023
Results First Posted
February 18, 2021
Record last verified: 2021-07