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

Idiopathic Parkinson Disease Clinical Trial

— PRO-Go  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944785
• Other study ID #: USWM-SA1-4001
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease

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