Trial Condition(s):

Multiple Sclerosis

Investigating the relationship between sleep, quality of life,other disorders and therapies in MS patients on Betaferon (BetaSleep)

Bayer Identifier:

16352

ClinicalTrials.gov Identifier:

NCT01766063

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The study aims to investigate the relationship between sleep quality, quality of life,other disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.

Inclusion Criteria
-  Patients ≥ 18 years of age with relapsing remitting multiple sclerosis or a clinically isolated syndrome and an expanded disability status scale score ≤5.
 -  Patients must be on treatment with Betaferon and tolerate Betaferon according to the investigator’s evaluation, but should not have received Betaferon longer than six months. 
 -  Written informed consent must be obtained
Exclusion Criteria
-  Patients who do not tolerate Betaferon according to the investigator’s evaluation or have been treated with Betaferon for more than six months.
 -  Patients receiving any other disease modifying drug or MS specific treatments
 -  Contraindications of Betaferon described in the Summary of Product Characteristics.

Trial Summary

Enrollment Goal
138
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 

Trial Design