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Long-term Follow-up of Fingolimod Phase II Study Patients

NCT02307838 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2017-03-23

Study results available
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Summary

This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).

Conditions

  • Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

Interventions

OTHER

Assessments arm

Protocol required assessments not provided in standard of care

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Poland
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

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 NCT02307838 on ClinicalTrials.gov