NCT00313976

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).

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

7 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
Last Updated

March 10, 2015

Status Verified

December 1, 2008

First QC Date

April 11, 2006

Last Update Submit

March 9, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisEarly secondary progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Magnetic Resonance Imaging (MRI): T2-lesions

    At week 104

Secondary Outcomes (6)

  • 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)

    At week 104

  • Hospitalizations

    At week 104

  • Neutralizing antibodies

    At week 104

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Arm 2

EXPERIMENTAL
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Interventions

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

250 micrograms every other day, subcutaneously for 104 weeks

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Ask Contact, Denmark

Location

Unknown Facility

Copenhagen, DK-2100, Denmark

Location

Unknown Facility

Hillerød, DK-3400, Denmark

Location

Unknown Facility

Holstebro, DK-7500, Denmark

Location

Unknown Facility

Stockholm, 11281, Sweden

Location

Unknown Facility

Stockholm, 14186, Sweden

Location

Unknown Facility

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Chronic Progressive

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Last Updated

March 10, 2015

Record last verified: 2008-12

Locations

DK(4)SE(3)