Condition or disease | Intervention/treatment |
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Idiopathic Parkinson Disease | Drug: XADAGO (safinamide) |
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 Type : | Observational |
Actual Enrollment : | 164 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 30, 2017 |
Actual Primary Completion Date : | December 23, 2019 |
Actual Study Completion Date : | January 10, 2020 |
Group/Cohort | Intervention/treatment |
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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
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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.
Other Names:
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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bob James, PharmD | US WorldMeds LLC |
Tracking Information | |||||
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First Submitted Date | May 1, 2019 | ||||
First Posted Date | May 10, 2019 | ||||
Results First Submitted Date | November 25, 2020 | ||||
Results First Posted Date | February 18, 2021 | ||||
Last Update Posted Date | February 18, 2021 | ||||
Actual Study Start Date | November 30, 2017 | ||||
Actual Primary Completion Date | December 23, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | 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 | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Parkinson's Disease patients who have been newly prescribed XADAGO | ||||
Condition | Idiopathic 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.
Other Names:
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Study Groups/Cohorts | 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
Intervention: Drug: XADAGO (safinamide)
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
164 | ||||
Original Estimated Enrollment |
540 | ||||
Actual Study Completion Date | January 10, 2020 | ||||
Actual Primary Completion Date | December 23, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 30 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03944785 | ||||
Other Study ID Numbers | USWM-SA1-4001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | US WorldMeds LLC | ||||
Study Sponsor | US WorldMeds LLC | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | US WorldMeds LLC | ||||
Verification Date | January 2021 |