Clinical trial NCT01490840: Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis
Official title: A 6-month, Multicenter, Randomized, Controlled Parallel Group Study to Evaluate the Effect of Physical Training on Fatigue in Patients With Relapsing-remitting Multiple Sclerosis Treated With Fingolimod, Followed by a 6 Month Optional Extension Phase
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fatigue in Multiple Sclerosis
Keywords: Fatigue
MS
Multiple Sclerosis
Exercise
Physical activity
Physical training
Fingolimod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 enrollment and low participant compliance to the physical training schedule.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test
timeFrame: baseline, 6 months
measure: Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength
timeFrame: baseline, 6 months
measure: Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance
timeFrame: baseline, 6 months
measure: Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)
timeFrame: Baseline, 6 months, 12 months
measure: Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)
timeFrame: Baseline, 6 months
measure: Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)
timeFrame: Baseline, 6 months
measure: Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill
timeFrame: Baseline, 6 months
measure: Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Alzenau
country: Germany
facility: Novartis Investigative Site
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Bad Mergentheim
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Böblingen
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Erbach
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Prien
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Sinsheim
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Teupitz
country: Germany
facility: Novartis Investigative Site
city: Unterhaching
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Maurer M, Schuh K, Seibert S, Baier M, Hentschke C, Streber R, Tallner A, Pfeifer K. A randomized study to evaluate the effect of exercise on fatigue in people with relapsing-remitting multiple sclerosis treated with fingolimod. Mult Scler J Exp Transl Clin. 2018 Feb 14;4(1):2055217318756688. doi: 10.1177/2055217318756688. eCollection 2018 Jan-Mar.