Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)

• Status: Unknown status
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 condition of the optical nerve in comparison to no medicinal therapy during 12 months and to assess the use of Optical Coherence tomography (OCT), a non-invasive ophthalmological technique, in daily practice as an alternative to magnetic resonance imaging (MRI) scanning for follow-up of these patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amphia Hospital
• Collaborators: Sanofi; TEVA Pharmachemie
• Treatments: (T,G)-A-L; Glatiramer Acetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.