Multiple Sclerosis
Conditions
Brief summary
* 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.
Interventions
DRUGGlatiramer acetate
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fatigue impact scale | at baseline, month 6 and month 12 |
Secondary
| Measure | Time frame |
|---|---|
| relapse rate | at baseline, month 6 and month 12 |
| quality of life | at baseline, month 6 and month 12 |
| depression | at baseline, month 6 and month 12 |
| disability | at baseline, month 6 and month 12 |
| Adverse events | at baseline, month 6 and month 12 |
Countries
Czechia
Outcome results
None listed