CompletedPhase 4DMT

Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

Sponsored by Novartis Pharmaceuticals

NCT ID
NCT01317004
Target Enrollment
61 participants
Start Date
2011-05
Est. Completion
2014-06

About This Study

The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).

Conditions Studied

Relapsing Remitting Multiple Sclerosis

Interventions

  • Fingolimod
  • Standard MS DMT

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
* Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
* An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
* Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
* Naïve to treatment with fingolimod.

Exclusion Criteria:

* A manifestation of MS other than those defined in the inclusion criteria.
* A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Patients with uncontrolled diabetes mellitus (HbA1c \> 7%).
* Diagnosis of macular edema during Screening Phase.

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations (17)

Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Ponderano, BI, Italy
Novartis Investigative Site
Caltanissetta, CL, Italy
Novartis Investigative Site
Cuneo, CN, Italy
Novartis Investigative Site
Como, CO, Italy
Novartis Investigative Site
Catania, CT, Italy
Novartis Investigative Site
Foggia, FG, Italy
Novartis Investigative Site
Castelfiorentino, FI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy

+7 more locations

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source