Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University at Buffalo Neurosurgery.
Recruitment status was  Recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University at Buffalo Neurosurgery

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014