Study to Compare Double-Dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS) - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00313976

Purpose

The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)	Phase III

MedlinePlus related topics: MRI Scans Multiple Sclerosis

Drug Information available for: Interferons Interferon beta Interferon-beta Interferon beta-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Scandinavian, Randomized, Rater-Blinded Study of Single and Double-Dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis

Further study details as provided by Bayer:

Primary Outcome Measures:

Magnetic Resonance Imaging (MRI): T2-lesions [ Time Frame: At week 104 ]

Secondary Outcome Measures:

Further Magnetic Resonance Imaging (MRI) parameters [ Time Frame: At week 104 ]
Relapses [ Time Frame: At week 104 ]
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS) [ Time Frame: At week 104 ]
Hospitalizations [ Time Frame: At week 104 ]
Neutralizing antibodies [ Time Frame: At week 104 ]
Adverse events [ Time Frame: At week 104 ]

Enrollment:

0

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) 250 micrograms every other day, subcutaneously for 104 weeks
Arm 2: Experimental	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) 2x250 micrograms every other day, subcutaneously for 104 weeks

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of MS for no less than one year and no longer than ten years
Disease in the secondary progressive (SP) phase
At least one relapse the last 3 years
Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months

Exclusion Criteria:

Serious or acute heart disease
Severe depression
Serious or acute liver, kidney or bone marrow dysfunction
Epilepsy not adequately treated
Pregnancy or lactation
Alcohol or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313976

Locations

Denmark

Copenhagen, Denmark, DK-2100

Holstebro, Denmark, DK-7500

Hillerød, Denmark, DK-3400

ask Contact, Denmark
Sweden

Stockholm, Sweden, 14186

Stockholm, Sweden, 171 76

Stockholm, Sweden, 11281

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91449, EudraCT: 2005-001540-23, 309560
Study First Received:	April 11, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00313976
Health Authority:	Sweden: Medical Products Agency; Denmark: Danish Medicines Agency

Keywords provided by Bayer:

Multiple Sclerosis
Early secondary progressive Multiple Sclerosis

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta-1b
Interferon-beta

Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Chronic Progressive

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009