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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 is a Phase 2 study that was terminated before completion, run by Newron Pharmaceuticals SPA. The registered enrollment target is 5 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01264861
The ClinicalTrials.gov registry entry for NCT01264861 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 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 1 intervention - of which Safinamide is the first listed.
NCT01264861 reports 0 study locations.
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.
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