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Oral Cladribine in Early Multiple Sclerosis (MS)
NCT00725985 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 617 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00725985 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00725985?
The interventions under investigation include: Placebo (DRUG), Cladribine (DRUG), Rebif® new formulation (RNF) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00725985?
This trial is sponsored by EMD Serono Research & Development Institute, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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