N/A
Completed N=164
Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
Idiopathic Parkinson Disease
Source: ClinicalTrials.gov NCT03944785 ↗
Enrolled (actual)
164
Serious AEs
6.1%
Results posted
Feb 2021
Primary outcomePrimary: Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) — -5.0; -1.0; -1.9; 0.0 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
-5.0; -1.0; -1.9; 0.0; -2.3; -2.6 | — |
| PRIMARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Scores |
-1.8; 0.5; -0.5 | — |
| PRIMARY Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score. |
0.0; 0.9; 0.4 | — |
| PRIMARY Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores |
56.0; 38.9; 41.0 | — |
| PRIMARY Clinical Global Impression of Change (CGI-C) |
0; 1; 13; 1; 7; 29 | — |
| PRIMARY Patient Global Impression of Change (PGI-C) |
0; 1; 9; 2; 3; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Patient (and Care Partner, if required per Inclusion Criterion 6) is able to understand and provide signed informed consent and HIPAA authorization in English.
- Patient with diagnosis of idiopathic PD (all stages).
- Independent of the study, clinician's and patient's choice of treatment is XADAGO in accordance with the Package Insert indication.
- 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.
- Patient has access to an electronic device for the interim completion of PROs.
- 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
- 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.).
- 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.
- 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.
- 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).
- Severe or unpredictable dyskinesia at the time of the Baseline Visit.
- Previous participation in this study; a patient may not re-enroll after prior discontinuation or completion
Data sourced from ClinicalTrials.gov (NCT03944785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.