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

Novartis

Status and phase: Terminated; Phase 4

Conditions: Fatigue in Multiple Sclerosis

Treatments: Other: Physical exercise

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490840

2011-002969-38 (EudraCT Number)

CFTY720DDE07

Details and patient eligibility

About

This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.

Full description

In this study, it was planned to randomize 226 participants. However, only 178 participants were randomized during a timeframe of 2 years and 8 months. Therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.

Enrollment: 178 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

178 participants in 2 patient groups

E-training

Experimental group

Description:

Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.

Treatment:

Other: Physical exercise

Waiting

Experimental group

Description:

Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 months waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.

Treatment:

Other: Physical exercise