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OpenTrials
Completed

NCT Number: NCT01127750

Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Box Hill, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years of age, must have relapsing MS

Exclusion criteria

  • Patients with a type of MS that is not relapsing
  • Patients with history of chronic immune disease
  • Patients with a history of certain cancers
  • Diabetic patients with certain eye disorders
  • Patients who are on certain immunosuppressive medications or heart medications
  • Patients with certain heart conditions
  • Patients with certain lung conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

FTY720

Drug

Primary outcomes

  1. Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS

    Time frame: 4 months

Secondary outcomes

  1. Incidence of macular edema

    Time frame: 4 months

  2. Incidence of bradyarrhythmic electrocardiograms (ECGs)

    Time frame: 4 months

  3. Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 21, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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