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Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE (PREMiSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450072
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : May 11, 2016
Information provided by (Responsible Party):
University at Buffalo Neurosurgery

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Selective Venography followed by therapeutic balloon angioplasty Other: Control arm Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sham Comparator: Control arm
Venography and sham angioplasty
Other: Control arm
Venography and sham angioplasty

Active Comparator: Active arm
therapeutic balloon angioplasty
Device: Selective Venography followed by therapeutic balloon angioplasty
Venography followed by therapeutic balloon angioplasty

Primary Outcome Measures :
  1. Safety [ Time Frame: 24 hours-1 month ]
    - Percent (%) of patients with Severe Adverse Events (SAE) measured at 24 hours (Immediate) and 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. . The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. For Phase II study, the immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.

Secondary Outcome Measures :
  1. Preliminary efficacy [ Time Frame: 1 month, 3 months, 6 months, and 1 yearfollowing ]
    - Restoration of venous outflow (more than 75% of normal outflow) as measured by the combined ECD/TCD and MRV at 1 month, 3 months, 6 months, and 1 yearfollowing the angioplasty as compared to baseline as well as compared to a parallel control group of MS patients that will undergo only selective venography without balloon angioplasty (sham-angioplasty). These comparisons will be accomplished by the hierarchical linear model which takes into account the correlation within subjects. Based on the residuals, we will check the normality assumptions by the normal quantile plot and skewness.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450072

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United States, New York
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14209
Sponsors and Collaborators
University at Buffalo Neurosurgery
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Principal Investigator: Adnan Siddiqui, MD, PhD University at Buffalo Neurosurgery
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University at Buffalo Neurosurgery Identifier: NCT01450072    
Other Study ID Numbers: NSG1730210B
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases