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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2023 |
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Main ID: |
NCT03944785 |
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Date of registration:
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01/05/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
PRO-Go |
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Scientific title:
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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 |
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Date of first enrolment:
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November 30, 2017 |
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Target sample size:
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164 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03944785 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Najeebah Abdul-Musawir, MD,MBA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Supernus Pharmaceuticals, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Parkinson Disease
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Intervention(s)
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Drug: XADAGO (safinamide)
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Primary Outcome(s)
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Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score.
[Time Frame: Baseline to Study Day 60]
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Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
[Time Frame: Baseline to Study Day 60]
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores
[Time Frame: Baseline to Study Day 60]
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Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
[Time Frame: Study Day 60]
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Clinical Global Impression of Change (CGI-C)
[Time Frame: Study Day 60]
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Patient Global Impression of Change (PGI-C)
[Time Frame: Study Day 60]
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Secondary ID(s)
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USWM-SA1-4001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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