Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Clinically Isolated Syndrome; Multiple Sclerosis

• Registration Number: NCT02671682
• Lead Sponsor: Albert Christian Ludolph, Prof.

Brief Summary

This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Study Start: 2016-02-26
• Primary Completion: 2019-01-03
• Study Completion: 2019-01-25
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
• informed consent
• age ≥ 12 years old

Exclusion Criteria

• clinical or laboratory signs of infection
• intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Multiple Sclerosis Functional Composite (MSFC)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Response Rate	4 weeks	defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value
EuroQol (EQ5D-5L)	2 and 4 weeks
Vision	4 weeks	defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2)
Visually Evoked Potentials (VEP; P100 latency)	4 weeks
Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)	4 weeks
Verbaler Lern- und Merkfähigkeitstest (VLMT) score	4 weeks
MSFC	2 weeks
Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)	4 weeks
Thickness of Ganglion Cell Layer (GCL) in OCT	4 weeks
Symbol Digit Modalities Test (SDMT) score	4 weeks
Expanded Disability Status Scale (EDSS)	2 and 4 weeks

Trial Locations

Locations (1)

Department of Neurology, University of Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany