check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
15307
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Depression and fatigue in MS patients treated with Betaferon.
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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
567Trial Dates
May 2010 - June 2013Phase
N/ACould I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Poland |
Primary Outcome
- Changes of fatigue score over timedate_rangeTime Frame:short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Changes of depression score over timedate_rangeTime Frame:short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
- Treatment adherencedate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Clinical course of the diseasedate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Overall treatment tolerability as measured by rate of adverse eventsdate_rangeTime Frame:12 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
Biological/VaccineTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A