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

Multiple Sclerosis Clinical Trial

Official title:

Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671682
• Other study ID #: IAPEMS
• Status: Completed
• Phase: N/A
• Start date: February 26, 2016
• Est. completion date: January 25, 2019

Study information

• Verified date: September 2019
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 25, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Sclerosis
• Syndrome

Intervention

Procedure:
• Immunoadsorption

• Plasmapheresis

Locations

Country	Name	City	State
Germany	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Albert Christian Ludolph, Prof.

Country where clinical trial is conducted

Germany, 

Outcome

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