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Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

NCT01534182 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2014-08-08

Study results available
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Summary

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Fingolimod

0.5 mg orally once a day

DRUG

Interferon beta - 1a (IFN)

44 mcg subcutaneously three times a week

DRUG

Glatiramer acetate (GA)

20 mg subcutaneously once a day

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Russia

Study Locations

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Entities

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 NCT01534182 on ClinicalTrials.gov