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)

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Peter Fuhr, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01765361
First received: December 21, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • dΣ-EP [ Time Frame: Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • d#-EP [ Time Frame: Baseline, 48 weeks, 96 weeks (RMS)/ Baseline, 48 weeks, 120 weeks (PPMS) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • definitive inclusion in one of the phase III trials on OCR: RRMS patients in "Opera I" (WA21092B) or "Opera II" (WA21093), 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765361

Locations
Switzerland
Dep. Neurology, Hospital of the University of Basel Recruiting
Basel, Switzerland, 4031
Contact: Martin Hardmeier, MD    +41 (0)61 265 41 51    bschermesser@uhbs.ch   
Principal Investigator: Martin Hardmeier, MD         
Sponsors and Collaborators
Peter Fuhr
  More Information

No publications provided

Responsible Party: Peter Fuhr, Head of the Division of Clinical Neurophysiology and Deputy Head of Dep. Neurology, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01765361     History of Changes
Other Study ID Numbers: EP-OCR
Study First Received: December 21, 2012
Last Updated: January 8, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014