Multiple Sclerosis
Conditions
Keywords
Inflammation, Multiple Sclerosis, Glatiramer Acetate, Gd enhancing lesions, 1.5T protocol, 3T protocol, Magnetization transfer imaging (MTI), Lesion activity analysis, Copaxone
Brief summary
This study will: * Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol. * Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols. * Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA. This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.
Detailed description
Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard protocol.
Interventions
DRUGCopaxone
12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
Sponsors
Teva Neuroscience, Inc.
University at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Age 18-65 * Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of \>9 T2 lesions in addition to 1 Gd lesion) * Have EDSS scores less than or equal to 5.5 * Have disease duration of 3 months to 30 years * None of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. | Change from baseline at 180 days and change from baseline at 360 days |
Countries
United States
Participant flow
Recruitment details
Recruitment from the pool of relapsing-remitting multiple sclerosis patients (RRMS) at the Jacob's Neurological Institute (JNI) was open for approximately one year.
Pre-assignment details
All enrolled patients had to meet all inclusion criteria and no exclusion criteria. Patients were to be 18-65 years of age, have a disease duration of 3months to 20 years, be diagnosed with RRMS according to McDonald criteria, one enhancing lesion 30 days prior to screening and an EDSS score equal to or below 5.5.
Participants by arm
| Arm | Count |
|---|---|
| Patients Diagnosed With Multiple Sclerosis Who Have the Presen Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | Patients Diagnosed With Multiple Sclerosis Who Have the Presen |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 7.823 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
Population: Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Diagnosed With Multiple Sclerosis Who Have the Presen | A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. | GAD lesions from 0-180 | -3.7 GAD lesions (number of) | Standard Deviation 5.8 |
| Patients Diagnosed With Multiple Sclerosis Who Have the Presen | A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol. | GAD lesion from 0-360 | -3.6 GAD lesions (number of) | Standard Deviation 4.2 |