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NCT00725985 · ClinicalTrials.gov registry record · Phase 3
Oral Cladribine in Early Multiple Sclerosis (MS)
A Phase 3 study of Multiple Sclerosis, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 617
- Enrollment target
- 20
- Study locations
NCT00725985 is a Phase 3 study of Multiple Sclerosis that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 617 participants, roughly in line with the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT00725985, a Phase 3 study of Multiple Sclerosis, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 617 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cladribine
- DRUG Rebif® new formulation (RNF)
Study Locations (20)
New York
- Upstate Clinical Research LLC 3 - Albany
- Neurological Specialists of Long Island - Great Neck
- Multiple Sclerosis Center of Northeastern NY - New York
- Comprehensive MS Care Clinic at South Shore Multiple Sclerosis - Patchogue
Colorado
- University of Colorado at Denver Health Sciences - Denver
- Fort Collins Neurology - Fort Collins
Florida
- MS Center of Brevard MIMA Centry Research Associates - Melbourne
- University of South Florida - Tampa
Michigan
- Michigan Neurology Associates - Clinton Township
- Henry Ford Hospital - Detroit
Arizona
- Hope Research Institute Medical Plaza LLC Desert Hills - Phoenix
California
- Multiple Sclerosis Center Drive, Neurology Suite 701 - Newport Beach
Georgia
- MS Center of Atlanta - Atlanta
Iowa
- Bruce Hughes West Building - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2008-12-31 |
| Est. Completion | 2012-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00725985
The ClinicalTrials.gov registry entry for NCT00725985 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 617 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00725985 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT00725985 about?
NCT00725985 is a clinical study titled "Oral Cladribine in Early Multiple Sclerosis (MS)". A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment per...
What is the current status of trial NCT00725985?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2008-12-31. Estimated completion is 2012-04-30.
What conditions does trial NCT00725985 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT00725985?
The interventions under investigation include: Placebo (DRUG), Cladribine (DRUG), Rebif® new formulation (RNF) (DRUG).
Who is sponsoring clinical trial NCT00725985?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00725985 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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