- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450072
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE (PREMiSE)
May 10, 2016 updated by: University at Buffalo Neurosurgery
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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Buffalo, New York, United States, 14209
- University at Buffalo Neurosurgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control arm
Venography and sham angioplasty
|
Venography and sham angioplasty
|
Active Comparator: Active arm
therapeutic balloon angioplasty
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Venography followed by therapeutic balloon angioplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours-1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month, 3 months, 6 months, and 1 yearfollowing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adnan Siddiqui, MD, PhD, University at Buffalo Neurosurgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
October 6, 2011
First Submitted That Met QC Criteria
October 7, 2011
First Posted (Estimate)
October 12, 2011
Study Record Updates
Last Update Posted (Estimate)
May 11, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSG1730210B (HSIRB - SUNY Buffalo)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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