Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Highresolution Electroencephalography (EEG)

Multiple Sclerosis Clinical Trial

Official title:

Assessment of Ocrelizumab (OCR) Treatment Effects on Functional Impairment of MS Patients Enrolled in the Phase III Orchestra Programme Using Multimodal Evoked Potentials (EP) and Highresolution Electroencephalography (EEG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765361
• Other study ID #: EP-OCR
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: January 31, 2017
• Start date: September 2012
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multiple Sclerosis (MS) is not only an 'inflammatory' demyelinating disease, but also includes axonal and neuronal injury in the grey matter . Neurodegenerative processes are partly independent of lesion formation and relapse activity , but represent the direct driver of clinical long-term disability and cognitive decline.

Multimodal evoked potentials (EP), i.e. the combination of visual, somato-sensory and motor EP (VEP, SSEP, MEP) have been shown prospectively to provide objective, monovectorial, and numerical data which are closely correlated to the EDSS. As EP capture the functional integrity of the examined systems they represent a method unbiased for directional changes, while remaining specific for the neuronal function, and hence can measure deterioration, as well as improvement, a germane advantage to capture drug response.

High-resolution electroencephalography (EEG) allow for explorative analysis of potential surrogate markers for cognitive decline.

Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody has shown strong treatment effects on number of T1Gd-enhancing lesions , on new T1Gd-enhancing and new T2-hyperintense lesions as well as on the annualized relapse rate in a recent phase II trial in relapsing-remitting MS.

The present study will investigate the effects of OCR on multimodal evoked potentials (EP), Furthermore, quantitative EEG as a potential correlate of cognitive dysfunction and fatigue will be explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2017
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• definitive inclusion in one of the phase III trials on OCR: relapsing remitting multiple sclerosis (RRMS) patients in "Opera I" (WA21092B) or "Opera II" (WA21093), primary progressive multiple sclerosis (PPMS) patients in "Oratorio" (WA25046B) and fulfilling the respective inclusion criteria

• stable clinical state (at least 4 weeks after treatment with corticoids, when there was a relapse)

• Provision of written informed consent and ability to be compliant with the schedule of assessments of the present study

Exclusion Criteria:

• exclusion criteria of both phase III trials on OCR also apply to the present study

• additionally patients with movable metal implants, e.g. pace-maker, stents, deep brain stimulators are excluded; (patients with jaw- or bone-fixed metal implants can be included)

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
Switzerland	Dep. Neurology, Hospital of the University of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dS-EP	The primary outcome measure is the change in the sum score of multimodal EP (dS-EP) after two years, which will be compared between treatment groups.	Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS)
Secondary	d#-EP	Secondary outcome measures are the change in number of abnormal EP (d#-EP) as well as change in cognitive performance and fatigue at two years.	Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS)