Clinical trial NCT03944785: Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson Disease
Keywords: Parkinson's disease
Safinamide
Xadago
MAO-B inhibitor
off
non-motor symptoms
motor symptoms
levodopa
PD
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-10
Enrollment: 164
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's Disease patients who have been newly prescribed XADAGO

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Baseline to Study Day 60
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores
timeFrame: Baseline to Study Day 60
measure: Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.
timeFrame: Baseline to Study Day 60
measure: Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
timeFrame: Study Day 60
measure: Clinical Global Impression of Change (CGI-C)
timeFrame: Study Day 60
measure: Patient Global Impression of Change (PGI-C)
timeFrame: Study Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Alabama Neurology Associates
state: Alabama
city: Bakersfield
country: United States
facility: Movement Disorders Neurology, Inc.
state: California
city: Laguna Hills
country: United States
facility: B.E.S.T. Center of Orange County
state: California
city: Los Gatos
country: United States
facility: Valley Parkinson Clinic
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Vernon
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Naples
country: United States
facility: Neuron Research
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of SW Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital Clinical Research Cener
state: Florida
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Richmond
country: United States
facility: Baptist Health System
state: Kentucky
city: Gray
country: United States
facility: Southeast Neuroscience Center, LLC
state: Louisiana
city: Springfield
country: United States
facility: Lester and Cox Medical Center
state: Missouri
city: Lake Success
country: United States
facility: Neurological Associates of Long Island, PC
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: Hickory
country: United States
facility: FryeCare Neurology
state: North Carolina
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma
state: Oklahoma
city: Lititz
country: United States
facility: Neurology and Stroke Associates
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Lubbock
country: United States
facility: Covenant Medical Group
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist - Sugar Land
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Health
state: Texas
city: Alexandria
country: United States
facility: Inova Medical Group- Neurology I
state: Virginia
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Virginia
city: Tacoma
country: United States
facility: Puget Sound Neurology
state: Washington
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Najeebah Abdul-Musawir, MD,MBA
role: STUDY_DIRECTOR
References: