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NCT00094172 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT00094172: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00094172 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00094172, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients. Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance.
Primary Outcome
The occurrence of ≥ T2 lesions\[1\] with or without gadolinium lesion (Gd+) enhancement\[2\] or clinical exacerbation\[3\] through 12 months. A higher score indicates more severe disease 1. A new T2 lesion is an abnormal, hyperintense white-matter area visible on T2 weighted images that were not present on the baseline scan 2. A Gd+ enhancement is defined as a contrast enhancement visible on a new T2 lesion 3. A clinical exacerbation is a new neurological symptom that lasts more than 48 hours i
Interventions
- DRUG Placebo
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00094172 record still lists
NCT00094172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00094172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00094172 about?
NCT00094172 is a clinical study titled "Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis". Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The p...
What is the current status of trial NCT00094172?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2005-05. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00094172?
The interventions under investigation include: Placebo (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT00094172?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00094172's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 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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