Safety and efficacy of Safinamide (Xadago®) in apathy associated with Parkinson's disease
- Conditions
- Parkinson's diseaseTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-003254-17-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
-Male or female outpatients (aged 45 to 80 years inclusive)
-Diagnosis of idiopathic Parkinson's Disease (PD) according to the Movement Disorder Society PD Criteria, suffering for fluctuations and a Hoehn and Yahr Stage of I to III (mild to moderate motor severity) at Screening. The diagnosis will be based on medical history and neurological examination
-A total score > 20 on the Montreal Cognitive Assessment (MoCA)31
-Scoring 1 or more on the Apathy Item of the Neuropsychiatric Inventory32
-Clinical diagnosis of apathy as defined by Diagnostic Criteria for Apathy in Clinical Practice33
-Be able to speak, read, and write in the language in which the tests are written and must be able to perform all the assessments in this language
-Receiving treatment with dopaminergic therapy: levodopa (with or without entacapone) or levodopa plus dopamine agonists at a stable dose for at least four weeks prior to Screening and for the duration of the study.
-Understand and sign the appropriate approved Informed Consent Form of the Study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
-Diagnosis of moderate to severe dementia associated with PD, according to the Clinical Diagnostic Criteria for Dementia Associated with PD34.
-Subjects with active psychosis or major hallucinations, severe depression or delirium; current diagnosis of substance abuse or history of alcohol or drug abuse for 3 months prior to Visit 1 (Screening)
-Mental/physical/social condition which could preclude performing efficacy or safety assessments
-Severe white matter disease, multiple lacunar infarcts, or signs of significant vascular changes on Magnetic Resonance Imaging (MRI)
-Clinically significant or unstable medical or surgical condition and history of vascular disease (stroke) or melanoma, gastrointestinal, renal, hepatic, endocrine, pulmonary, or cardiovascular disease, including not well controlled hypertension, asthma, chronic obstructive pulmonary disease, and Type 1 diabetes that would, in the opinion of the Investigator, preclude participation to the study
-Any clinically relevant abnormality, either on medical history, physical and neurological examination, ECG, or by diagnostic laboratory tests that, in the opinion of then Investigator, could hinder participation to the study
-Currently experiencing significant motor complications (moderate or severe wearing off defined as score > 2 on Item 4.4 of MDS-UPDRS Part IV) or disabling dyskinesia (defined as score > 2 on Item 4.2 of MDS-UPDRS Part IV)35
-Currently participating to another clinical trial or who participated in a previous clinical trial within 30 days prior to Visit 1 (Screening) or who received any investigational product within 30 days or five half-lives, whichever was longer, prior to Visit 1 (Screening)
-Previously treated with safinamide
-Patients recently started with anticholinergic medication or acetylcholinesterase inhibitors or changes in drug doses within 4 weeks prior to the Screening visit.
-Use of MAO-B inhibitors (e.g., selegiline, rasagiline) within 4 weeks prior to Visit 1 (Screening).
-Active psychosis or currently receiving antipsychotic treatment
-Patients taking memantine or antagonists of dopamine receptors (except domperidone) within 4 weeks prior to Visit 1 (Screening)
-Subjects who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study
-Women who are pregnant, lactating, or who are attempting to conceive
-Women of childbearing potential not willing to use an adequate contraceptive method (unless surgically sterilized) for 4 weeks prior to, during, and 4 weeks after the last dose of trial medication
-Known hypersensitivity to the trial treatment(s), including placebo
-Legal incapacity or limited legal capacity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method