Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 3 study of Multiple Sclerosis, sponsored by EMD Serono Research & Development Institute.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

CDMS according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to Multiple Sclerosis \[MS\]) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (\>=) 1 point if baseline EDSS was between \>= 1.0 and less than or equal to (=\<)

Conditions Studied

Multiple Sclerosis

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

FieldValue
Enrollment Target 617 participants
Start Date 2008-12-31
Est. Completion 2012-04-30
Phase Phase 3
EMD Serono Research & Development Institute

81 total trials

What the finished NCT00725985 record still lists

NCT00725985 is an interventional study that assigns participants to a tested intervention. The registered 617 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target.

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 names 20 study sites across 14 states, led by 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.

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 NCT00725985's enrollment target sits among peer trials

617 40th of 315 higher than 276 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02610179 · 617 participants · NA

    Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial

  • NCT05672927 · 618 participants · Phase 4

    Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

  • NCT06220721 · 618 participants · NA

    Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia

  • NCT04813185 · 616 participants · NA

    Preventing Retaliatory Gun Violence in Violently Injured Adults

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT00725985, the US trial registry maintained by the National Library of Medicine. NCT00725985 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.