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Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
Plain-language guide to NCT00937157: not phased interventional trial of Glatiramer Acetate, multiple sclerosis, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00937157
- Phase
- not phased
- Status
- completed
- Start
- 2007-09
- Completion (planned or actual)
- 2010-07
- Participants
- 12 (actual)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Multiple Sclerosis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Glatiramer Acetate for multiple sclerosis.
It had 1 arm (groups): 1 (other).
Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
The registry classes the interventions as drug.
More on the Plan
Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS).
Who Took Part
12 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients diagnosed with clinically definite MS according to the McDonald criteria. Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse. Have EDSS scores less than or equal to 5.5. Have disease duration of 3 months to 30 years. None of the.
The full record lists 7 inclusion and 1 exclusion criteria.
How the Study Was Run
It was run as a single-group and open-label study.
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 2007-09 with completion listed for 2010-07.
It ran at 1 site in United States.
Its stated primary purpose is diagnostic.
What Was Measured
Researchers chose this as the main measure: A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol (time frame: Change from baseline at 180 days and change from baseline at 360 days).
What This Means in Plain Language
Put simply, this is a not phased trial of Glatiramer Acetate in 12 people with multiple sclerosis.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.