Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- Drug: Safinimide 50-100 mg/dayDrug: Matching Placebo
- Registration Number
- NCT00627640
- Lead Sponsor
- Newron Pharmaceuticals SPA
- 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 to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in man.
Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.
The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 549
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)
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Safinimide 50-100 mg/day 1 active (50 - 100 mg/day) 2 Matching Placebo -
- Primary Outcome Measures
Name Time Method Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia) 24 weeks
- Secondary Outcome Measures
Name Time Method Evaluate the changes from baseline to W24 in Activities of Daily Living, cognition, dyskinesias, change in global clinical status, motor symptoms, motor fluctuations, change in levopoda dose and Health Related Quality of life 24 weeks
Trial Locations
- Locations (120)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
Parkinson's Institute
🇺🇸Sunnyvale, California, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorder Center
🇺🇸Albany, New York, United States
Neurologic Consultants P.A.
🇺🇸Fort Lauderdale, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Parkinson's Disease Treatment Center of SW Florida
🇺🇸Port Charlotte, Florida, United States
Scroll for more (110 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States