← Human Trials & Peer-Reviewed Studies
FOCUS Fatigue Outcome in Copaxone USers
Plain-language guide to NCT00267319: phase 4 non-randomized trial of Glatiramer Acetate, multiple sclerosis, 111 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00267319
- Phase
- phase 4
- Status
- completed
- Start
- 2003-06
- Completion (planned or actual)
- 2006-10
- Participants
- 111 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Multiple Sclerosis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.
* 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.
It had 1 arm (groups): single group (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 111 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: hypersensitivity to glatiramer acetate or mannitol,; previous treatment with copaxone.
How the Study Was Run
Design: non-randomized, single-group and open-label.
Being open-label, the Glatiramer Acetate study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2003-06 with completion listed for 2006-10.
It ran at 1 site in Czechia.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): fatigue impact scale (time frame: at baseline, month 6 and month 12).
It also tracked 5 secondary outcomes, for example relapse rate, quality of life, depression, disability and Adverse events.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Glatiramer Acetate in 111 people with multiple sclerosis.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Glatiramer Acetate compound page, Multiple sclerosis research.
Our Notes on the Compound
Glatiramer Acetate: A mix of synthetic amino-acid chains (Copaxone) used in relapsing multiple sclerosis.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.