Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Svenningsson
• Collaborator: Västerbotten County Council, Sweden
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Rituximab

Criteria

Inclusion Criteria:

• Between the age of 18 and 65 years of age (nonfertile women or fertile women with effective contraceptive methods)

• Progressive MS since at least three years

• Some kind of documented progression of neurological symptoms during the previous two years.

• Expanded Disability Status Scale (EDSS) 4,0 - 7.0 (inclusive) (basically spared arm functions)

• Conventional therapy not indicated, contraindicated or failed

• Judged as compliant with the protocol

Exclusion Criteria:

• Eligible for any of the conventional MS therapies

• Relapsing remitting multiple sclerosis (RRMS)

• Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture

• Cognitive defect making informed consent unreliable

• Any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist

• Severe, uncontrolled heart disease

• Pregnant or lactating women

• Patients having contraindication for or otherwise not compliant with MRI investigations

• Documented vulnerability to infections

• Simultaneous treatment with other immunosuppressive drugs

• Documented allergy or intolerance to Rituximab

• Severe psychiatric condition