MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
Public ClinicalTrials.gov record NCT00605683. 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 Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
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 nigrostriatal dopaminergic 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. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
Study identification
- NCT ID
- NCT00605683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 679 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
- Nov 2007 (Type not available)
- Primary completion
- Jan 2012 (Actual)
- Completion
- Mar 2012 (Actual)
- Last update posted
- Oct 29, 2013
2007 – 2012
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | — | — |
| Arizona Neurological Institute | Phoenix | Arizona | — | — |
| Pacific Neuroscience Medical Group | Oxnard | California | — | — |
| 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 | — | — |
| Emory University | Atlanta | Georgia | — | — |
| Medical College of Georgia | Augusta | Georgia | — | — |
| Columbus Research Institute | Columbus | Georgia | — | — |
| Northwestern University PD and Movement Disorders 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 | — | — |
| Parkinson's Disease and Movement Disorders Center of Albany | Albany | New York | — | — |
| North Shore Medical Center | Manhasset | New York | — | — |
| Columbia University Medical Center | New York | New York | — | — |
| New York University | New York | New York | — | — |
| The Neurological Institute | Charlotte | North Carolina | — | — |
| Duke University Health Systems | Druham | North Carolina | — | — |
| Cleveland Clinic | Cleveland | Ohio | — | — |
| Neurology Specialists | Dayton | Ohio | — | — |
| Oregon Health & Science University | Portland | Oregon | — | — |
| Lankenau Hospital | Wynnewood | Pennsylvania | — | — |
| Butler Hospital | Providence | Rhode Island | — | — |
| 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 94 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00605683, 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 Oct 29, 2013 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00605683 live on ClinicalTrials.gov.