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

NCT00235989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-05-08

Study results available
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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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Interferon beta 1b (Betaseron, BAY86-5046)

250 mcg administered s.c.(subcutaneous) every other day

DRUG

Interferon beta 1b (Betaseron, BAY86-5046)

250 mcg administered s.c. every other day (for patients having received 500 mcg before)

DRUG

Interferon beta 1b (Betaseron, BAY86-5046)

500 mcg administered s.c. every other day

DRUG

Interferon beta 1b (Betaseron, BAY86-5046)

500 mcg administered s.c. every other day (for patients having received 250 mcg before)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00235989 on ClinicalTrials.gov