Study to Compare Double-dose Betaferon to the Approved Do... | NCT00313976

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 11, 2006

First Submission Date that Met QC Criteria

Apr 11, 2006

First Posted Date

Apr 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2015

Last Update Posted Date

Mar 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Arm 2	Experimental		Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)	Drug	250 micrograms every other day, subcutaneously for 104 weeks	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Magnetic Resonance Imaging (MRI): T2-lesions		At week 104

Secondary Outcomes

Measure	Description	Time Frame
Further Magnetic Resonance Imaging (MRI) parameters		At week 104
Relapses		At week 104
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

ID	Term
D009103	Multiple Sclerosis
D020528	Multiple Sclerosis, Chronic Progressive

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Facility	Status	City	State	ZIP	Country	Contacts
		Ask Contact			Denmark

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

ID	Type	Description	Link
EudraCT: 2005-001540-23
309560