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)

NCT01765361 | Completed

• 1 other identifier: EP-OCR
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• dΣ-EP

  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 Outcomes (1)

• d#-EP

  Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Dep. Neurology, Hospital of the University of Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Fuhr, MD, Prof.

  University Hospital, Basel, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 10, 2013
• Study Start: September 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

CH (1)