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

October 6, 2011
October 7, 2011
June 2010
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01450072 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Multiple Sclerosis
  • Device: Selective Venography followed by therapeutic balloon angioplasty
    Venography followed by therapeutic balloon angioplasty
  • Other: Control arm
    Venography and sham angioplasty
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Cheryl Kennedy, LMSW, MPH 716-859-7068
Contact: Jennifer Gay 716-887-5200 ext 2107 jgay@ubns.com
United States
 
NCT01450072
NSG1730210B
Yes
University at Buffalo Neurosurgery
University at Buffalo Neurosurgery
Not Provided
Principal Investigator: Adnan Siddiqui, MD, PhD University at Buffalo Neurosurgery
University at Buffalo Neurosurgery
October 2011

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