Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
Public ClinicalTrials.gov record NCT00627640. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00627640
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 549 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2009 (Type not available)
- Primary completion
- Jan 2012 (Actual)
- Completion
- Mar 2012 (Actual)
- Last update posted
- Mar 29, 2013
2009 – 2012
United States locations
- U.S. sites
- 28
- U.S. states
- 16
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | — | — |
| Barrow Neurological Institute | Phoenix | Arizona | — | — |
| Mayo Clinic Scottsdale | Scottsdale | Arizona | — | — |
| San Francisco Clinical Research Center | San Francisco | California | — | — |
| Parkinson's Institute | Sunnyvale | California | — | — |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | — | — |
| Parkinson's Disease and Movement Disorder Center | Boca Raton | Florida | — | — |
| Neurologic Consultants P.A. | Fort Lauderdale | Florida | — | — |
| University of Florida | Gainesville | Florida | — | — |
| Parkinson's Disease Treatment Center of SW Florida | Port Charlotte | Florida | — | — |
| Neurology Clinical Research Inc. | Sunrise | Florida | — | — |
| University Of South Florida Medical Center | Tampa | Florida | — | — |
| Wesley Woods Geriatric Center | Atlanta | Georgia | — | — |
| Columbus Research Institute | Columbus | Georgia | — | — |
| Northwestern University PD and Movement Disorders Center | Chicago | Illinois | — | — |
| Rush University Medical Center | Chicago | Illinois | — | — |
| University of Kansas Medical Center | Kansas City | Kansas | — | — |
| University of Maryland Medical Center | Baltimore | Maryland | — | — |
| Boston University School of Medicine | Boston | Massachusetts | — | — |
| Quest Research Institute | Bingham Farms | Michigan | — | — |
| Parkinson's Disease and Movement Disorder Center | Albany | New York | — | — |
| North Shore Medical Center | Manhasset | New York | — | — |
| Neurological Institute of New York | New York | New York | — | — |
| The Neurological Institute | Charlotte | North Carolina | — | — |
| Duke Movement Disorders Clinic | Durham | North Carolina | — | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | — | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | — | — |
| Baylor College of Medicine | Houston | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 93 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00627640, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2013 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00627640 live on ClinicalTrials.gov.