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

This is an interventional treatment trial for Fatigue in Multiple Sclerosis focused on measuring Fatigue, MS, Multiple Sclerosis, Exercise, Physical activity, Physical training, Fingolimod Read More

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.