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NCT01264861 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging
A Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01264861: Clinical Trial Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
NCT01264861 is a Phase 2 study that was terminated before completion, run by Newron Pharmaceuticals SPA. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01264861, a Phase 2 study, was terminated before completion, sponsored by Newron Pharmaceuticals SPA.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a study of safinamide, an investigational drug for Parkinson disease (PD). Safinamide is being developed as add-on therapy for the treatment of Parkinson disease. It is theorized that safinamide acts by increasing the available dopamine in those areas of the brain where dopamine is decreased as a result of Parkinson;s Disease. . Dopamine in the brain is involved in controlling body movements. Safinamide has been extensively studied in animals, and has been shown to increase the level of dopamine in these animals. Safinamide has also been tested in patients with Parkinson disease. The goal of this research trial is to see if safinamide is safe and well tolerated and to better understand how it affects the dopamine system in the brain in individuals with Parkinson disease. Data from this trial may provide essential information about the effectiveness and safety of these doses of safinamide in patients with early Parkinson disease, who are already receiving a stable dose of their normal Parkinson disease treatment.
Interventions
- DRUG Safinamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-01-24 |
| Phase | Phase 2 |
Why NCT01264861 stopped before completion
NCT01264861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Safinamide is the first listed.
NCT01264861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01264861 about?
NCT01264861 is a clinical study titled "A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging". This is a study of safinamide, an investigational drug for Parkinson disease (PD). Safinamide is being developed as add-on therapy for the treatment of Parkinson disease. It is theorized that safinamide acts by increasing the available dopamine in those areas of the brain where dopamine is decreased...
What is the current status of trial NCT01264861?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2011-03. Estimated completion is 2012-01-24.
What interventions are being tested in trial NCT01264861?
The interventions under investigation include: Safinamide (DRUG).
Who is sponsoring clinical trial NCT01264861?
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 NCT01264861's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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