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Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

NCT01333501 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2017-03-21

Study results available
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Summary

The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate which test of the battery is the most sensitive in detecting differences between treatment groups.

Conditions

Interventions

DRUG

Fingolimod

0.5 mg in capsules for oral administration once daily

DRUG

Interferon beta 1b

250 μg injected s.c. every other 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
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Germany
  • Italy

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 NCT01333501 on ClinicalTrials.gov