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NCT00627640 · ClinicalTrials.gov registry record · Phase 3
Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
A Phase 3 study, sponsored by Newron Pharmaceuticals SPA.
- Completed
- Registry status
- Phase 3
- Development phase
- 549
- Enrollment target
NCT00627640: Completed Phase 3 study, sponsored by Newron Pharmaceuticals SPA.
NCT00627640 is a Phase 3 study that has completed, run by Newron Pharmaceuticals SPA. The registered enrollment target is 549 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00627640, a Phase 3 study, has completed, sponsored by Newron Pharmaceuticals SPA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 549 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Matching Placebo
- DRUG Safinimide 50-100 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00627640 record still lists
NCT00627640 is an interventional study that assigns participants to a tested intervention. The registered 549 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT00627640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00627640 about?
NCT00627640 is a clinical study titled "Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa". 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 brai...
What is the current status of trial NCT00627640?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 549 participants. The study started on 2009-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00627640?
The interventions under investigation include: Matching Placebo (DRUG), Safinimide 50-100 mg/day (DRUG).
Who is sponsoring clinical trial NCT00627640?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00627640's enrollment target sits among peer trials
549 689th of 2000 higher than 1,312 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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