NCT01264848

Brief Summary

The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1 multiple-sclerosis

Timeline
Completed

Started Mar 2010

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

7 months

First QC Date

December 21, 2010

Last Update Submit

February 9, 2015

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisvenous insufficiency

Outcome Measures

Primary Outcomes (1)

  • Change in clinical symptoms of multiple sclerosis measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance

    6 months after the procedure

Study Arms (1)

Balloon angioplasty and/or stenting

EXPERIMENTAL

Balloon angioplasty and/or stenting of stenosed internal jugular vein and/or azygous vein and/or brachiocephalic vein

Procedure: balloon angioplasty and/or stenting

Interventions

balloon angioplasty and/or stentingPROCEDURE

balloon angioplasty and/or stenting of internal jugular veins and/or azygous vein and/or brachiocephalic veins

Balloon angioplasty and/or stenting

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with clinically defined multiple sclerosis

You may not qualify if:

  • contraindication for endovascular procedure performed in local anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Euromedic Specialist Clinics

Katowice, Poland

Location

MeSH Terms

Conditions

Multiple SclerosisVenous Insufficiency

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marian Simka

    Euromedic Specialist Clinics , Katowice , Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 22, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2012

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

PL(1)