Status:
TERMINATED
A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging
Lead Sponsor:
Newron Pharmaceuticals SPA
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This is a study of safinamide, an investigational drug for Parkinson disease (PD). Safinamide is being developed as add-on therapy for the treatment of Parkinson disease. It is theorized that safinami...
Eligibility Criteria
Inclusion
- Male or female, between 40-80 years of age.
- Subject must have a diagnosis of idiopathic Parkinson's disease, and a Hoehn and Yahr stage of I-III.
- Subjects must be concomitantly treated with a stable dose of a single dopamine agonist prior to the screening visit.
- Subjects must be able to understand and willing to sign an approved Informed Consent form.
- Female subjects must be neither pregnant or breast-feeding.
Exclusion
- Subjects with any form of Parkinsonism other than idiopathic Parkinson's disease.
- Subjects currently experiencing motor fluctuations (end of dose wearing off), dyskinesias, or significant postural hypotension.
- Subjects treated with l-dopa, anticholinergics, amantadine, MAO inhibitors, COMT inhibitors, tricyclic antidepressants, and / or SSRI and SNRI antidepressants.
- Subjects with a history of psychosis, either previously or currently, or a score ≥ 3 on item 2 or 3 of the UPDRS Part I.
- Subjects with evidence of dementia or cognitive dysfunction.
- Subjects with current diagnosis of substance abuse or history of alcohol or drug abuse in the past three months.
- Subjects with current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease, and Type I diabetes.
- Subjects with a concomitant disease likely to alter absorption, metabolism or elimination of the study drug.
- Female subjects must be neither pregnant nor lactating.
- Subjects with hypersensitivity or contraindications to MAO-B inhibitors.
- Subjects with a neoplastic disorder, which is either currently active or has been in remission for less than one year.
- Subjects with second- or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within three months of the screening visit, or significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
- Subjects with a history or a current diagnosis of human immunodeficiency virus infection, or tests positive for Hepatitis B surface antigen, tests positive for Hepatitis B core antibody, but negative for Hepatitis B surface antibody, or tests positive for Hepatitis C antibodies.
- Subjects who have participated in a previous clinical trial with safinamide, have participated in a previous clinical trial within 30 days of entry into the study, or have received treatment with any investigational compound within thirty days or five half-lives, whichever is longer, prior to screening.
- Subjects with any abnormality that the investigator deems to be clinically relevant.
- Legal incapacity or limited legal capacity
- Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
- Treatment with a drug that has hepatotoxic potential within 4 weeks, or received radiation therapy or a drug with cytotoxic potential within one year prior to the screening visit.
- Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity, retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation, or diabetic retinopathy.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01264861
Start Date
March 1 2011
End Date
January 24 2012
Last Update
September 18 2017
Active Locations (1)
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1
Molecular Neuroimaging, LLC
New Haven, Connecticut, United States, 06510