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)

January 31, 2017 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Dep. Neurology, Hospital of the University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be a sub-sample of the above mentioned multi-center, randomized, double-blind, phase III trials ("Oratorio", "Opera I" and "Opera II") and will comprise approximately 100 PPMS and 100 RRMS patients. Treatment groups will only be disclosed after completion of the phase III trials.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dΣ-EP
Time Frame: Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS)
The primary outcome measure is the change in the sum score of multimodal EP (dΣ-EP) after two years, which will be compared between treatment groups.
Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
d#-EP
Time Frame: Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Director: Peter Fuhr, MD, Prof., University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-OCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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