DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

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

Phase: Phase 3

Status: Withdrawn

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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).

Clinical Details

Official title: A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Magnetic Resonance Imaging (MRI): T2-lesions

Secondary outcome:

Further Magnetic Resonance Imaging (MRI) parameters

Relapses

Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)

Hospitalizations

Neutralizing antibodies

Adverse events

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

ask Contact, Denmark

Copenhagen DK-2100, Denmark

Hillerød DK-3400, Denmark

Holstebro DK-7500, Denmark

Stockholm 11281, Sweden

Stockholm 14186, Sweden

Stockholm 171 76, Sweden

Additional Information

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product


Last updated: March 9, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017