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NCT00235989 · ClinicalTrials.gov registry record · Phase 2

Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

A Phase 2 study of Multiple Sclerosis (Relapsing Remitting), sponsored by Bayer.

Completed
Registry status
Phase 2
Development phase
63
Enrollment target
17
Study locations

NCT00235989: Completed Phase 2 study of Multiple Sclerosis (Relapsing Remitting), sponsored by Bayer.

NCT00235989 is a Phase 2 study of Multiple Sclerosis (Relapsing Remitting) that has completed, run by Bayer. The registered enrollment target is 63 participants, below the 560-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (89% lower). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00235989, a Phase 2 study of Multiple Sclerosis (Relapsing Remitting), has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 2
Development phase
63 participants
Enrollment target
17
Study locations

Study Summary

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Primary Outcome

Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was rep

Interventions

  • DRUG Interferon beta 1b (Betaseron, BAY86-5046)

Study Locations (17)

North Carolina

  • - Durham
  • - High Point
  • - Winston-Salem

California

  • - Los Angeles
  • - San Francisco

Michigan

  • - Ann Arbor
  • - Ann Arbor

Tennessee

  • - Nashville
  • - Nashville

District of Columbia

  • - Washington D.C.

Georgia

  • - Atlanta

Illinois

  • - Chicago

Kansas

  • - Kansas City

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2003-06
Est. Completion 2008-01
Phase Phase 2
Bayer

591 total trials

What the finished NCT00235989 record still lists

NCT00235989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 560-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Multiple Sclerosis (Relapsing Remitting) appearing as the primary indexed condition, and to 1 intervention - of which Interferon beta 1b (Betaseron, BAY86-5046) is the first listed.

NCT00235989 lists 17 locations in 12 states (North Carolina, California, Michigan).

Frequently Asked Questions

What is clinical trial NCT00235989 about?

NCT00235989 is a clinical study titled "Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis". The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

What is the current status of trial NCT00235989?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2003-06. Estimated completion is 2008-01.

What conditions does trial NCT00235989 study?

This clinical trial studies the following conditions: Multiple Sclerosis (Relapsing Remitting).

What interventions are being tested in trial NCT00235989?

The interventions under investigation include: Interferon beta 1b (Betaseron, BAY86-5046) (DRUG).

Who is sponsoring clinical trial NCT00235989?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00235989 being conducted?

This trial has 17 study locations across California, District of Columbia, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Multiple Sclerosis (Relapsing Remitting)

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 NCT00235989's enrollment target sits among peer trials

63 19th of 29 higher than 11 of 29 other Multiple Sclerosis (Relapsing Remitting) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Sclerosis (Relapsing Remitting) 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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Source: ClinicalTrials.gov NCT00235989, the US trial registry maintained by the National Library of Medicine. NCT00235989 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.