Status:
UNKNOWN
Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)
Lead Sponsor:
Amphia Hospital
Collaborating Sponsors:
Sanofi
TEVA Pharmachemie
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
This is a study in patients with clinically isolated syndrome (CIS) and early relapsing remitting multiple sclerosis (RRMS) to assess the effects of glatiramer acetate (GA) subcutaneously on the condi...
Detailed Description
Multiple sclerosis (MS) is a progressive and demyelinating disease of the central nervous system characterized by inflammation and neurodegeneration. It is characterized by an ongoing process of demye...
Eligibility Criteria
Inclusion
- Age: 18 - 55 years
- Early relapsing remitting MS, defined as a disease course less than 3 years
- clinically isolated syndrome , defined as optic neuritis (ON) or other than ON
- Currently treated with glatiramer (GA) or currently not treated for MS
- Expanded disability status scale (EDSS) score 0-5
- Able and willing to provide written informed consent prior to enrolment
- Willing and able to comply with the protocol requirements for the duration of the study
Exclusion
- Clinical definite multiple sclerosis with a disease course more than 3 years
- Primary progressive multiple sclerosis
- Secondary progressive multiple sclerosis
- Current use of any approved or investigational disease modifying agents for the treatment of MS other than GA.
- Neuromyelitis Optica (Devic's disease)
- Any condition that may interfere with the quality of the OCT scan: clouding of the media, i.e. cataract, pupil which are hard to dilate.
- Contra-indications for Copaxone ® as defined in the Summary of Product Characteristics (SPC) text
- Hypersensitivity to GA or mannitol
- Subject's inability to complete the study or if the subject is considered by the investigator to be for any reason, an unsuitable candidate for this study.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00910598
Start Date
September 1 2009
End Date
June 1 2012
Last Update
February 10 2010
Active Locations (2)
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1
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
2
Maasland Ziekenhuis
Sittard, Netherlands