Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PR
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Selective Venography followed by therapeutic balloon angioplasty
Placebo
- Control arm
Results by group
Percentage of Patients With Immediate and Short-term SAE
24 hours-1 month
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Control Arm | 0 Participants | 10 | |
| Active Arm | 0 Participants | 9 |
Control Arm
Active Arm
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Control Arm | 10 | 0 (0.0%) | |
| Active Arm | 9 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Patients With Immediate and Short-term SAE
24 hours-1 month
Safety
Other measures (1)
Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty
1 month, 3 months, 6 months, and 1 year post-angioplasty
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 6.5
Show the full criteria
Inclusion criteria
* Age 18-65 years * EDSS 0-6.5 (0-5.5 in the phase II of the study) * Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005) * 1 relapse within the past 12 months or GAD positive lesion on an MRI within the past 3 months (only for phase II of the study) * Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri or steroids (within the last 30 days prior to enrollment) * Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section) * Normal renal function: creatinine clearance level of >60
Exclusion criteria
* Relapse, disease progression and Tysabri and steroid treatment in the 30 days preceding study entry * Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.) * Severe peripheral chronic venous insufficiency * Abnormal renal function * Contrast allergy (anaphylaxis) * Not accepting to undergo the endovascular treatment * Peripheral Vascular Disease
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis (MS).
Papers
Loading reviews and guidelines…
History
Started
Jun 2010
Main results due
Dec 2011
Finished
Dec 2012
Results posted
Jun 2025