Interventional Clinical Trial for CCSVI in Multiple Sclerosis Patients
Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Catheter venography with balloon venoplasty
- Catheter venography with balloon venoplasty and balloon
What it measured
Main measures
Adverse Events
48 weeks
Safety
Other measures (1)
Clinical Outcome
48 weeks
FatiguePainQuality of life (reported by participants)MRI lesions
Who could take part
Relapsing and progressive · 18 to 65 · EDSS 0 to 6.5
Show the full criteria
Inclusion criteria
* Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary Progressive MS according to the McDonald criteria 2010 * Age 18 to 65 years inclusive * Neurostatus (EDSS) score at screening from 0 to 6.5 * Fulfill ultrasound criteria for CCSVI
Exclusion criteria
* Previous venoplasty and/or stenting of extra cranial venous system
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To investigate the safety and tolerability of balloon venoplasty compared to sham in Multiple Sclerosis patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI) as measured by adverse events occurring within 48 weeks of the procedure.
Papers
Loading reviews and guidelines…
History
Started
May 2013
Main results due
Aug 2017
Finished
Aug 2017