Status:
TERMINATED
Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Fatigue in Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01490840
Start Date
November 1 2011
End Date
July 1 2014
Last Update
May 12 2016
Active Locations (32)
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1
Novartis Investigative Site
Dortmund, Germany, Germany, 44135
2
Novartis Investigative Site
Leipzig, Germany, Germany, 04299
3
Novartis Investigative Site
Aachen, Germany, 52062
4
Novartis Investigative Site
Alzenau in Unterfranken, Germany, 63755