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

NCT00910598 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-02-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

glatiramer acetate

20 mg daily s.c. for 1 year

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • TEVA Pharmachemie

    collaborator UNKNOWN

  • Amphia Hospital

    lead OTHER

Principal Investigators

  • E.C.A.M. Sanders, MD · Amphia ziekenhuis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00910598 on ClinicalTrials.gov