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)
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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) |
- 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.
- 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 |
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.
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| 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 | |
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 May 23, 2013