Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04979650 |
| Other study ID # |
978445 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 22, 2021 |
| Est. completion date |
October 23, 2023 |
Study information
| Verified date |
July 2021 |
| Source |
Mazandaran University of Medical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
to determine the rate of asymptomatic gadolinium-enhancing lesions conversion to the
non-enhancing black hole (neBHs) with or without corticosteroid pulse therapy in patients
with RRMS, and to analyze if treatment of asymptomatic gadolinium enhancement lesions has any
effect on the expanded disability status scale. The study is performed in the MS clinic of Bu
Ali Sina Hospital in Sari and Mazandaran University of Medical Sciences. 104 recurrent MS
patients are admitted based on the admission criteria. They are divided into two groups of
intervention and control based on a simple randomization block. The intervention group
received 1 gram of methylprednisolone in 500 ccs of normal saline for 5 days and the control
group received only 500 ccs of serum. After 6 months, a new MRI is taken from the patients
and the possibility of asymptomatic active plaque conversion with or without intervention is
compared in the two groups, as well as the amount of EDSS in the two groups. They do not know
whether the patient is in the control group or the intervention.
Description:
Investigators perform a study on 104 consecutive patients with a diagnosis of RR-MS.
Participants will be selected for the study if they meet all of the following inclusion
criteria: (1) a baseline MRI scan with at least one CEL on contrast-enhanced T1-weighted
images (performed either at the time of the diagnosis or during the routine MRI monitoring of
the disease) and (2) a follow-up MRI scan performed at least 6 months later in the same
hospital site. Participants were then divided into two groups by block randomization (the
Block size will be 4): (1) participants with asymptomatic CELs, treated with a single cycle
of high-dose IVMP after baseline MRI (group A) and (2) participants with asymptomatic CELs
for clinical relapse and, therefore, not exposed to IVMP after baseline MRI (group B).
1. Microsoft Excel software will be used for block randomization with a group of 4.
2. Number the participants from 1 to 102.
3. In a group of 2, the possible combinations of blocks are:(A=Group1 and B=Group2)
1. ABBA 2. ABAB 3. BBAA 4. ABAB 5. BAAB 6. BABA
To determine the sample size for this study we used the result of Maria Di Gregorio and et
al.
This study will be double-blind patients and radiologist clinicians unaware of types of
interventions.
MRI examinations were performed with a 1.5 T magnet (General Electric Medical Systems,
Milwaukee, WI, USA) with a standard head coil. The MRI protocol used in our Neuroradiology
Section included the following sequences: (1) a T2-weighted-fluid-attenuated inversion
recovery (FLAIR) sequence with an inversion time (TI) of 2400 ms, an echo time (TE) of 120
ms, and a repetition time (TR) of 8000 ms; (2) a T2-weighted fast spin-echo (FSE) sequence
with a TE of 90 ms and a TR of 6600 ms; and (3) a spin-echo (SE) sequence for T1-weighted
images with a TR of 500 ms and a TE of 20 ms Post-contrast images were obtained with a scan
delay of 5 min after the injection of gadoterate (Dotarem, Guerbet group, Roissy, France) at
0.2 mmol/kg. 3-mm thick contiguous slices were obtained.
In the baseline MRI, the following characteristics of CELs were recorded: (1) number; (2)
maximum diameter (≤ or > 5 mm); (3) pattern of enhancement (homogeneous or ring enhancement);
(4) hypointensity as compared to normal-appearing surrounding white matter in baseline
T1-weighted images acute black hole (aBH); and (5) the fact of being symptomatic, as
established by an experienced neurologist (MDG) on the basis of CELs' localization and
clinical characteristics of the concomitant relapse. The follow-up MRI was performed with the
same 1.5 T magnet and using the same MRI protocol. At the follow-up MRI, the presence of
persistent black holes (pBHs) was recorded. Specifically, pBHs were defined as non-enhancing
T1 lesions hypointense with respect to the surrounding normal-appearing white matter and
concordant with hyperintense T2 lesions [10]. Three investigators (MDG, AP, and GR) in
agreement with a senior experienced neuro-radiologist (PF) revised baseline CELs and
follow-up pBHs' characteristics. The three investigators and the neuroradiologist were
blinded to the exposure of the patients to IVMP treatment
