Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

This study is currently recruiting participants.

Verified October 2011 by University at Buffalo Neurosurgery

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2011

Last Updated Date

October 7, 2011

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01450072 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

Official Title ^ICMJE

Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Device: Selective Venography followed by therapeutic balloon angioplasty
Venography followed by therapeutic balloon angioplasty
Other: Control arm
Venography and sham angioplasty

Study Arm (s)

Sham Comparator: Control arm
Venography and sham angioplasty

Intervention: Other: Control arm
Active Comparator: Active arm
therapeutic balloon angioplasty

Intervention: Device: Selective Venography followed by therapeutic balloon angioplasty

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Cheryl Kennedy, LMSW, MPH	716-859-7068
Contact: Jennifer Gay	716-887-5200 ext 2107	jgay@ubns.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01450072

Other Study ID Numbers ^ICMJE

NSG1730210B

Has Data Monitoring Committee

Yes

Responsible Party

University at Buffalo Neurosurgery

Study Sponsor ^ICMJE

University at Buffalo Neurosurgery

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Adnan Siddiqui, MD, PhD

University at Buffalo Neurosurgery

Information Provided By

University at Buffalo Neurosurgery

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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