Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
This study is currently recruiting participants.
Verified October 2011 by University at Buffalo Neurosurgery
Sponsor:
University at Buffalo Neurosurgery
Information provided by (Responsible Party):
University at Buffalo Neurosurgery
ClinicalTrials.gov Identifier:
NCT01450072
First received: October 6, 2011
Last updated: October 7, 2011
Last verified: October 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Device: Selective Venography followed by therapeutic balloon angioplasty Other: Control arm |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE |
Resource links provided by NLM:
Further study details as provided by University at Buffalo Neurosurgery:
Primary Outcome Measures:
- Safety [ Time Frame: 24 hours-1 month ] [ Designated as safety issue: Yes ]- 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:
- Preliminary efficacy [ Time Frame: 1 month, 3 months, 6 months, and 1 yearfollowing ] [ Designated as safety issue: No ]- 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450072
Contacts
| Contact: Cheryl Kennedy, LMSW, MPH | 716-859-7068 | |
| Contact: Jennifer Gay | 716-887-5200 ext 2107 | jgay@ubns.com |
Locations
| United States, New York | |
| University at Buffalo Neurosurgery | Recruiting |
| Buffalo, New York, United States, 14209 | |
| Principal Investigator: Adnan Siddiqui, MD, PhD | |
Sponsors and Collaborators
University at Buffalo Neurosurgery
Investigators
| Principal Investigator: | Adnan Siddiqui, MD, PhD | University at Buffalo Neurosurgery |
More Information
No publications provided
| Responsible Party: | University at Buffalo Neurosurgery |
| ClinicalTrials.gov Identifier: | NCT01450072 History of Changes |
| Other Study ID Numbers: | NSG1730210B |
| Study First Received: | October 6, 2011 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013