FOCUS Fatigue Outcome in Copaxone USers
Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 20 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
What it measured
Main measures
fatigue impact scale
at baseline, month 6 and month 12
Fatigue
Other measures (5)
relapse rate
at baseline, month 6 and month 12
Relapsesquality of life
at baseline, month 6 and month 12
Quality of life (reported by participants)depression
at baseline, month 6 and month 12
Mood and sleepdisability
at baseline, month 6 and month 12
Adverse events
at baseline, month 6 and month 12
Safety
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* relapsing-remitting Multiple Sclerosis (MS), * at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment, * ambulant patients i.e disability score EDSS MAX 5,5, * clinically stable MS * relapse free and steroid free at least 30 days prior to start copaxone treatment
Exclusion criteria
* hypersensitivity to glatiramer acetate or mannitol, * pregnancy, * fertile female not willing to use effective contraception, * previous treatment with copaxone The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
* The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis. * Secondary outcome measures are:disability, relapse rate, quality of life and depression.
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History
Started
Jun 2003
Main results due
Oct 2006