Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis

Inclusion Criteria:

• Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
• Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including)
• Immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline
• Fatigue score assessed by mFIS of equal or greater than 14 at screening
• Neurologically stable with no evidence of relapse within 30 days prior to inclusion date

Exclusion Criteria:

• Patients who have been treated with:

  • systemic corticosteroids or immunoglobulins within 1 month prior to randomization;
  • immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to randomization;
  • monoclonal antibodies (including natalizumab) within 3 months prior to randomization;
  • mitoxantrone within 6 months prior to randomization
  • cladribine at any time.
• Patients with any medically unstable condition, as assessed by the primary treating physician at each site.

• Patients with any of the following cardiovascular conditions :

  • history of cardiac arrest;
  • history of myocardial infarction or with current unstable ischemic heart disease;
  • history of angina pectoris due to coronary spasm or history of Raynaud syndrome
  • Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the investigator;
  • history or presence of a second-degree AV block, Type II or a third-degree AV
  • block
  • patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or
  • III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide,
  • dofelitide);
  • proven history of sick sinus syndrome or sino-atrial heart block;
  • uncontrolled hypertension
• Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training
• Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator`s discretion

Other protocol-defined inclusion/exclusion criteria may apply.