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NCT01451723 · ClinicalTrials.gov registry record · Phase 2
Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II
A Phase 2 study, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01451723: Clinical Trial Phase 2 study, sponsored by Louisiana State University Health Sciences Center in New Orleans.
NCT01451723 is a Phase 2 study that was terminated before completion, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451723, a Phase 2 study, was terminated before completion, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one year between people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.
Primary Outcome
The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD \<30 will be used. A spatial anysotropic exponential covariance structure will be used.
Interventions
- OTHER Placebo
- DRUG Polyphenon E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
Why NCT01451723 stopped before completion
NCT01451723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01451723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01451723 about?
NCT01451723 is a clinical study titled "Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II". The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one year between people with MS treated with P...
What is the current status of trial NCT01451723?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2011-07. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01451723?
The interventions under investigation include: Placebo (OTHER), Polyphenon E (DRUG).
Who is sponsoring clinical trial NCT01451723?
This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01451723's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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