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MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
NCT00605683 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Safinamide (as add-on therapy)
Study Locations (20)
Florida
- Parkinson's Disease and Movement Disorder Center — Boca Raton
- Neurologic Consultants P.A. — Fort Lauderdale
- University Of Florida — Gainesville
- Parkinson's Disease Treatment Center of SW Florida — Port Charlotte
- Neurology Clinical Research Inc. — Sunrise
- University Of South Florida Medical Center — Tampa
California
- Pacific Neuroscience Medical Group — Oxnard
- San Francisco Clinical Research Center — San Francisco
- Parkinson's Institute — Sunnyvale
Georgia
- Emory University — Atlanta
- Medical College of Georgia — Augusta
- Columbus Research Institute — Columbus
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- Arizona Neurological Institute — Phoenix
Connecticut
- Institute for Neurodegenerative Disorders — New Haven
Illinois
- Northwestern University PD and Movement Disorders Center — Chicago
Kansas
- University of Kansas Medical Center — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 679 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00605683
The ClinicalTrials.gov registry entry for NCT00605683 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 679 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Newron Pharmaceuticals SPA, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Idiopathic Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention — of which Safinamide (as add-on therapy) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00605683 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00605683 about?
NCT00605683 is a clinical study titled "MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist". 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 blo...
What is the current status of trial NCT00605683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 679 participants. The study started on 2007-11. Estimated completion is 2012-03.
What conditions does trial NCT00605683 study?
This clinical trial studies the following conditions: Idiopathic Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00605683?
The interventions under investigation include: Safinamide (as add-on therapy) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00605683?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00605683 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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