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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 is a Phase 3 study that has completed, run by Newron Pharmaceuticals SPA. The registered enrollment target is 549 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00627640
The ClinicalTrials.gov registry entry for NCT00627640 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 549 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Newron Pharmaceuticals SPA, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT00627640 reports 0 study locations.
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.
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