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NCT00011375 · ClinicalTrials.gov registry record · Phase 2
Rolipram to Treat Multiple Sclerosis
A Phase 2 study of Multiple Sclerosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT00011375: Completed Phase 2 study of Multiple Sclerosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00011375 is a Phase 2 study of Multiple Sclerosis that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 52 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00011375, a Phase 2 study of Multiple Sclerosis, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety, tolerability, and effect of the drug Rolipram on multiple sclerosis (MS). It will examine whether Rolipram can dampen the part of the immune response believed to lead to MS and reduce disease activity. Patient with multiple sclerosis who are between the ages of 18 and 65 may be eligible for this study. Candidates will be screened with a complete neurological and medical evaluation. Participants will complete three study phases-baseline, treatment and follow-up, as follows: Baseline (3 months) - Approximately four magnetic resonance imaging (MRI) scans will be obtained to assess MS activity. Participants with MS activity above a certain level will continue with the treatment phase. Treatment (8 months) - Patients will take Rolipram tablets in increasing doses every 2 to 3 days for the first month of this phase until their individual maximum tolerated dose is established. Dosing will continue at that level for the rest of the treatment phase. Dosing is in the morning, midday and evening. Patients will be seen monthly in the clinic for examination and MRI scans. Follow-up - Participants will have monthly exams and MRIs for 3 months following the treatment phase, after which their participation in the study ends. Patients' monthly visits during treatment and follow-up include a neurological examination to assess disease status; MRI to assess brain changes; and blood and urine collection to monitor liver, kidney and other functions. In addition, a lumbar puncture (spinal tap) is done during the last month of the baseline phase and one month after treatment ends to study changes in the spinal fluid surrounding the brain and spinal cord, and leukapheresis is done once during the last month of the baseline phase and once during the last month of treatment to collect white blood cells for study. These procedures involve the following: MRI uses a strong magnetic field and radio waves instead of X-rays to produce images showing struct
Conditions Studied
Interventions
- DRUG Rolipram
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2001-02 |
| Est. Completion | 2004-04 |
| Phase | Phase 2 |
What the finished NCT00011375 record still lists
NCT00011375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Rolipram is the first listed.
NCT00011375 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00011375 about?
NCT00011375 is a clinical study titled "Rolipram to Treat Multiple Sclerosis". This study will evaluate the safety, tolerability, and effect of the drug Rolipram on multiple sclerosis (MS). It will examine whether Rolipram can dampen the part of the immune response believed to lead to MS and reduce disease activity. Patient with multiple sclerosis who are between the ages of ...
What is the current status of trial NCT00011375?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2001-02. Estimated completion is 2004-04.
What conditions does trial NCT00011375 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT00011375?
The interventions under investigation include: Rolipram (DRUG).
Who is sponsoring clinical trial NCT00011375?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00011375 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00011375's enrollment target sits among peer trials
52 173rd of 315 higher than 141 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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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