Trial Condition(s):
Multiple Sclerosis
Depression and fatigue in MS patients treated with Betaferon. (FADO)
Bayer Identifier:
15307
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations.
The study is conducted in routine practice setting hence no interference with standard care takes place.
Pharmacologic treatments of MS-fatigue and depression will also be recorded.
Inclusion Criteria
- Relapsing-remitting multiple sclerosis - Age 18+ - Patients initiating Betaferon treatment
Exclusion Criteria
- Patients previously treated with any immunomodulatory drug
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
The short-term effect of immunomodulatory treatment with interferon beta-1b (Betaferon) on fatigue and depression in first-time treated patients with relapsing-remitting multiple sclerosis.
Trial Type:
Observational
Intervention Type:
Biological/Vaccine
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Changes of fatigue score over timeTimeframe: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
Secondary Outcome
- Changes of depression score over timeTimeframe: short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
- Treatment adherenceTimeframe: 12 months
- Clinical course of the diseaseTimeframe: 12 months
- Overall treatment tolerability as measured by rate of adverse eventsTimeframe: 12 months
Additional Information
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