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NCT00605683 · ClinicalTrials.gov registry record · Phase 3
MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
A Phase 3 study of Idiopathic Parkinson´s Disease, sponsored by Newron Pharmaceuticals SPA.
- Completed
- Registry status
- Phase 3
- Development phase
- 679
- Enrollment target
- 20
- Study locations
NCT00605683: Completed Phase 3 study of Idiopathic Parkinson´s Disease, sponsored by Newron Pharmaceuticals SPA.
NCT00605683 is a Phase 3 study of Idiopathic Parkinson´s Disease that has completed, run by Newron Pharmaceuticals SPA. The registered enrollment target is 679 participants, above the 123-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (452% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00605683, a Phase 3 study of Idiopathic Parkinson´s Disease, has completed, sponsored by Newron Pharmaceuticals SPA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 679 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT00605683 record still lists
NCT00605683 is an interventional study that assigns participants to a tested intervention. The registered 679 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (452% higher).
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.
NCT00605683 names 20 study sites across 11 states, led by Florida, California, Georgia.
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.
What interventions are being tested in trial NCT00605683?
The interventions under investigation include: Safinamide (as add-on therapy) (DRUG).
Who is sponsoring clinical trial NCT00605683?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 9 total clinical trials registered on ClinicalTrials.gov.
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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