Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

Completed · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT00627640

Run by

Newron Pharmaceuticals SPA

People needed

549

Starts

2009-02-01

Expected to finish

2012-03-01

Last updated by the study team

2013-03-29

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• 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 — Boca Raton, Florida, 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
• Neurology Clinical Research Inc. — Sunrise, Florida, United States
• University Of South Florida Medical Center — Tampa, Florida, United States
• Wesley Woods Geriatric Center — Atlanta, Georgia, United States
• Columbus Research Institute — Columbus, Georgia, United States
• Northwestern University PD and Movement Disorders Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Quest Research Institute — Bingham Farms, Michigan, United States
• Parkinson's Disease and Movement Disorder Center — Albany, New York, United States
• North Shore Medical Center — Manhasset, New York, United States
• Neurological Institute of New York — New York, New York, United States
• The Neurological Institute — Charlotte, North Carolina, United States
• Duke Movement Disorders Clinic — Durham, North Carolina, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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