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NCT01211587 · ClinicalTrials.gov registry record · Phase 2
A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease
A Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT01211587: Completed Phase 2 study, sponsored by Newron Pharmaceuticals SPA.
NCT01211587 is a Phase 2 study that has completed, run by Newron Pharmaceuticals SPA. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01211587, a Phase 2 study, has completed, sponsored by Newron Pharmaceuticals SPA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this research trial is to determine if safinamide (experimental drug) can improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The word "experimental" means the trial drug is not approved by Health Authorities (government authorities) and is still being tested for safety and effectiveness. Approximately one hundred (100) patients will participate in this research trial. The research trial will be conducted in approximately thirty (30) medical centers in the following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The research trial will last until June 2012.
Primary Outcome
Total score reduction in the PD-CRS at 12 weeks compared to the Baseline. The PD-CRS detects early cognitive impairment in Parkinson's disease. It is composed of 2 scales, the subcortical scale (items 1, 3, 4, 5, 7, 8, 9) and the cortical scale (items 2, 6). The total score of the subcortical scale is from 0 to 114. The total score of the cortical scale is from 0 to 20. The PD-CRS Total score represents the sum of scores on the cortical and subcortical scales. It ranges from 0 to 134. The more p
Interventions
- DRUG placebo
- DRUG safinamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2010-09 |
| Phase | Phase 2 |
What the finished NCT01211587 record still lists
NCT01211587 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01211587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01211587 about?
NCT01211587 is a clinical study titled "A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease". The purpose of this research trial is to determine if safinamide (experimental drug) can improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The word "experimental" means the trial drug is not approved by Health Authorities (government authorities) and is still b...
What is the current status of trial NCT01211587?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2010-09.
What interventions are being tested in trial NCT01211587?
The interventions under investigation include: placebo (DRUG), safinamide (DRUG).
Who is sponsoring clinical trial NCT01211587?
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 NCT01211587's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 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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