Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001781 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS)
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00001781 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 25 participants.
The verdict
NCT00001781, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown, but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that cause the body's immune system and natural defenses to attack healthy cells. In the case of MS, the immune system begins attacking myelin, the cells that make up the sheath covering nerves. Without myelin nerves are unable to transmit signals effectively and symptoms occur. Researchers are interested in testing the safety, tolerability, and effectiveness of a new therapy (CGP77116) for Multiple Sclerosis (MS). CGP77116 is a small protein similar to the protein in myelin. CGP77116 is designed to modify the immune reaction that destroys normal myelin. CGP77116 is an experimental therapy meaning it has not been approved by the U.S. Food and Drug Administration. However, in preliminary studies on animal it has been shown to be effective at modifying the autoimmune reaction associated with the development of MS. The purpose of this study is to assess the safety and effect of CGP77116 on disease activity in patients with Multiple Sclerosis as measured by magnetic resonance imaging (MRI) and immunological studies. The study is broken into three parts: I) BASELINE: in the first part of the study patients will undergo 6 MRIs over a 5 month period. During this time, patients will be evaluated based on the presence of MS lesions seen on MRI. Patients whose MS lesions are highly active will be entered into the second part of the study. II) TREATMENT: in the second part of the study, patients with active MS lesions will begin receiving CGP77116. The drug will be given by injection once a week for one month and then once a month for 8 additional months. III) FOLLOW-UP: in the third and final part of the study, patients will undergo an MRI every 2 months for 6 months and then every 3 months for 6 additional months. The results of the MRIs will be used to measure the effectiveness of CGP77116.
Interventions
- DRUG CGP 77116
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 1998-02 |
| Est. Completion | 2002-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001781
The ClinicalTrials.gov registry entry for NCT00001781 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CGP 77116 is the first listed.
NCT00001781 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001781 about?
NCT00001781 is a clinical study titled "Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS)". Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown, but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that cause the body's immune system and natural defenses to attack healthy cells. In the case of MS, the immune system be...
What is the current status of trial NCT00001781?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 1998-02. Estimated completion is 2002-03.
What interventions are being tested in trial NCT00001781?
The interventions under investigation include: CGP 77116 (DRUG).
Who is sponsoring clinical trial NCT00001781?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.