Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients

Manish Mehta, MD

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Procedure: Sham procedure (non-treatment); Procedure: Venoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01089686

LS10-01

Details and patient eligibility

About

This is a single center, multispecialty, randomized double blind placebo control feasibility clinical trial. The purpose is to evaluate the safety, feasibility and efficacy of percutaneous transluminal angioplasty in treating extracranial venous obstructive lesions, and its influence on the clinical outcomes of Multiple Sclerosis (MS) patients that have been found to have chronic cerebrospinal venous insufficiency (CCSVI).

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be 18 years old or greater and less than or equal to 65 years of age
• Score of 0 to 7 on the EDSS scale
• Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
• Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
• Informed consent signed by patient

Exclusion criteria

• Patient is unwilling to comply with the follow up
• Patient is pregnant
• Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
• Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
• Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
• Life expectancy is less than one year
• Lack of mental capacity to consent
• Creatinine level of greater than 2.5 or is dialysis dependant
• Enrollment in another clinical study

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups

Venoplasty (treatment)

Active Comparator group

Description:

Patients will be randomized to treatment or non-treatment arm with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the treatment arm of the study will receive venoplasty at the time of the diagnostic venogram.

Treatment:

Procedure: Venoplasty

Sham procedure (non-treatment)

Sham Comparator group

Description:

Patients will be randomized to treatment or non-treatment with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the non-treatment arm of the study will receive the diagnostic venogram only.

Treatment:

Procedure: Sham procedure (non-treatment)