Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

NCT01450072 | Completed Results DMC

• 1 other identifier: NSG1730210B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Immediate and Short-term SAE

  Percent (%) of patients with Severe Adverse Events (SAE) measured at 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. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.

  24 hours-1 month

Secondary Outcomes (1)

• Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty

  1 month, 3 months, 6 months, and 1 year post-angioplasty

Study Arms (2)

Control arm

SHAM COMPARATOR

Venography and sham angioplasty

Other: Control arm

Active arm

ACTIVE COMPARATOR

therapeutic balloon angioplasty

Device: Selective Venography followed by therapeutic balloon angioplasty

Interventions

Selective Venography followed by therapeutic balloon angioplasty DEVICE

Venography followed by therapeutic balloon angioplasty

Active arm

Control arm OTHER

Venography and sham angioplasty

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo Neurosurgery

Buffalo, New York, 14209, United States

Location

Related Publications (1)

• Siddiqui AH, Zivadinov R, Benedict RH, Karmon Y, Yu J, Hartney ML, Marr KL, Valnarov V, Kennedy CL, Ramanathan M, Ramasamy DP, Dolic K, Hojnacki DW, Carl E, Levy EI, Hopkins LN, Weinstock-Guttman B. Prospective randomized trial of venous angioplasty in MS (PREMiSe). Neurology. 2014 Jul 29;83(5):441-9. doi: 10.1212/WNL.0000000000000638. Epub 2014 Jun 27.

  PMID: 24975855 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Ellen Carl
• Organization: UBNS

ecarl@ubns.com

716-218-1000

Study Officials

• Adnan Siddiqui, MD, PhD

  University at Buffalo Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 12, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Locations

US (1)