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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03944785

Recruitment Status Completed

First Posted May 10, 2019

Last update posted February 24, 2020

Study Description

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.

  • Condition or Disease:Idiopathic Parkinson Disease
  • Intervention/Treatment: Drug: XADAGO (safinamide)
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 209 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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
  • Actual Study Start Date: November 2017
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: January 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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
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.
Outcome Measures
  • Primary Outcome Measures: 1. Change from baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Baseline to Study Day 60 ]
    MDS-UPDRS is a 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items) examines non-motor experiences of daily living, Part II (13 items) examines motor experiences of daily living, Part III (33 items) examines the cardinal motor disabilities of PD, and Part IV (6 items) examines motor complications. Each item has 0-4 ratings, where 0 (normal) to 4 (severe) and scores for each part is summed to calculate the total scores. The total score ranges from 0 to 260, with higher scores indicating worse outcomes.
  • 2. Change from baseline in Parkinson's Disease Questionnaire (PDQ-39) scores [ Time Frame: Baseline to Study Day 60 ]
    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 the maximum score of 156. Higher scores indicate worse outcomes.
  • 3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score. [ Time Frame: Baseline to Study Day 60 ]
    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.
  • 4. Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) scores [ Time Frame: Baseline to Study Day 60 ]
    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 30, with higher scores indicating better treatment satisfaction.
  • 5. Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline to Study Day 60 ]
    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 1 (very much improved) through to 7 (very much worse).
  • 6. Patient Global Impression of Change (PGI-C) [ Time Frame: Baseline to Study Day 60 ]
    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).
  • Secondary Outcome Measures: 1. Change from baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    MDS-UPDRS is a 4-part assessment of the multiple clinical disabilities of Parkinson's Disease. Part I (13 items) examines non-motor experiences of daily living, Part II (13 items) examines motor experiences of daily living, Part III (33 items) examines the cardinal motor disabilities of PD, and Part IV (6 items) examines motor complications. Each item has 0-4 ratings, where 0 (normal) to 4 (severe) and scores for each part is summed to calculate the total scores. The total score ranges from 0 to 260, with higher scores indicating worse outcomes.
  • 2. Change from baseline in Parkinson's Disease Questionnaire (PDQ-39) scores [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    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 the maximum score of 156. Higher scores indicate worse outcomes.
  • 3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score. [ Time Frame: Baseline to treatment extension period visits on study day 180 ]
    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.
  • 4. Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: Baseline to study day 30; treatment extension period visits on day 90, day 120 and day 180 ]
    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 30, with higher scores indicating better treatment satisfaction.
  • 5. Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    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 1 (very much improved) through to 7 (very much worse).
  • 6. Patient Global Impression of Change (PGI-C) [ Time Frame: Baseline to treatment extension period visits on study day 90 and day 180 ]
    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).
Eligibility Criteria
  • Ages Eligible for Study: 30 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Parkinson's Disease patients who have been newly prescribed XADAGO
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

Contacts and Locations
Contacts
Locations
Show 30 Study Locations
Sponsors and Collaborators

US WorldMeds LLC

Investigators

Principal Investigator: Bob James, PharmD, MBA US WorldMeds LLC

More Information
  • Responsible Party: US WorldMeds LLC
  • ClinicalTrials.gov Identifier: NCT03944785 History of Changes
  • Other Study ID Numbers: USWM-SA1-4001
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: February 24, 2020
  • Last Verified: February 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by US WorldMeds LLC: Parkinson's disease
    Safinamide
    Xadago
    MAO-B inhibitor
    non-motor symptoms
    levodopa
    off
    motor symptoms
    PD
  • Additional relevant MeSH terms: Parkinson Disease