EUCTR2009-015007-97-IT
Active, not recruiting
Phase 1
Retinal Nerve Fiber Layer (RNFL) as measured by Optical Coherence Tomography (OCT) to Depict axonal loss in Early RRMS treated with difFEreNt dosage of subCutaneous IFN bEta 1a - DEFENCE
DR. ENRICO MONTANARI0 sites144 target enrollmentOctober 1, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with RR-MS diagnosis
- Sponsor
- DR. ENRICO MONTANARI
- Enrollment
- 144
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •oRR\-MS diagnosis according to the revised Mc Donald criteria
- •oRRMS diagnosis within 2 years
- •oPatients of both sexes, aged 18\-50 years
- •oPatients DMDs treatment na?ve
- •oPatients valid informed consent to take part in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •oPrimary or secondary progressive MS
- •oPatients with previous DMD treatment courses
- •oPatients receiving oral or parenteral steroid or ACTH courses within the 30 days preceding visit 1 (prior to enrolment)
- •oPatients unwilling to comply with study requirements
- •oContra\-indications for IFN\-\&\#946;1a treatment as defined in the SmPC or hypersensitivity to any components of formulation
- •oSuffer of dementia (DSM IV criteria) with a SIDAM score \<33
- •oSuffer of major medical or psychiatric illness
- •oPrevious history of NORB
- •oContra\-indications for tropicamide: patients with a narrow angle between the iris and cornea; closed angle glaucoma; hypersensitivity to tropicamide or any excipients of the formulation
Outcomes
Primary Outcomes
Not specified
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