BENEFIT Extension Study

Multiple Sclerosis Clinical Trial

Official title:

Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544037
• Other study ID #: 91713
• Secondary ID: 311129
• Status: Completed
• Phase: N/A
• First received: October 15, 2007
• Last updated: March 2, 2012
• Start date: September 2007
• Est. completion date: January 2011

Study information

• Verified date: March 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyHungary: Medical Research Council Committee for Science and Research EthicsSpain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 50 Years

Eligibility

Inclusion Criteria:

• All patients randomized and treated at least once in study 304747

Exclusion Criteria:

• Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Standard Therapy for Multiple Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Slovenia,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study		End of Study	No

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