Status:
COMPLETED
Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
Lead Sponsor:
Newron Pharmaceuticals SPA
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
Brief Summary
Parkinson's Disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led t...
Eligibility Criteria
Inclusion
- Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off" phase.
- Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks.
- Have motor fluctuations, with \>1.5 hours "off" time during the day. Be able to maintain an accurate and complete diary (18-hour)
Exclusion
- Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;.
- Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.
- Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
- Have received treatment with safinamide previously. History of, or current depression psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive dysfunction. History of allergic response to anticonvulsants, levodopa, or other anti-Parkinsonian agents.
- Hypersensitivity or contraindications to MAO-B inhibitors. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT00627640
Start Date
February 1 2009
End Date
March 1 2012
Last Update
March 29 2013
Active Locations (121)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Barrow Neurological Institute
Phoenix, Arizona, United States
3
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
4
San Francisco Clinical Research Center
San Francisco, California, United States