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Evaluation of Natalizumab for thE Relief of MS Associated FatiGue (ENER-G)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00464074
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : July 8, 2011
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen

Brief Summary:
This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.

Condition or disease
Multiple Sclerosis

Detailed Description:

TYSABRI® treatment has already demonstrated significant improvement in the quality of life (QoL) of patients with MS. In particular, TYSABRI® add-on treatment to interferon beta-1a has demonstrated improvement in fatigue as measured by the Modified Fatigue Impact Scale (MFIS). Both patients and neurologists report that patients have experienced significant improvements in fatigue shortly after initiating TYSABRI® treatment. Fatigue is both a common and a disabling symptom of MS. Further, there is evidence that fatigue contributes to cognitive difficulties in patients with MS. This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.

The primary objective of this study is to determine the effects of TYSABRI® treatment on fatigue in subjects with relapsing forms of MS as measured by changes in patient-reported Visual Analog Scale for Fatigue (VAS-F).

Primary endpoint is the change in the following:

1. Visual Analog Scale for Fatigue (VAS-F) at three months after initiating treatment with TYSABRI®.

Secondary objectives are to measure changes in patient-reported Modified Fatigue Impact Scale (MFIS) and Fatigue Severity Scale (FSS).

Secondary endpoints are changes in the following:

  1. Modified Fatigue Impact Scale (MFIS)
  2. Fatigue Severity Scale (FSS)

The tertiary objective of this study is to explore for any effects of TYSABRI® treatment on cognition by assessing changes in the Automated Neuropsychology Assessment Metrics (ANAM).

Tertiary endpoints are changes in the Automated Neuropsychology Assessment Metrics (ANAM) consisting of:

  • Traditional Continuous Performance Test
  • Running Memory Continuous Performance Test
  • Simple Response Time
  • Procedural Response Time
  • Coding Substitution
  • Mathematics
  • Logical Relations
  • Matching-to-Sample
  • Stanford Sleepiness Scale

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects With Relapsing Forms of MS
Study Start Date : September 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Natalizumab




Primary Outcome Measures :
  1. Visual Analog Scale for Fatigue (VAS-F) [ Time Frame: at three months after initiating treatment with TYSABRI® ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
multicenter clinic patients
Criteria

Inclusion Criteria:

  1. Diagnosis of relapsing forms of MS.
  2. Patients having an inadequate response to or unable to tolerate alternate MS therapies.
  3. Patient must be enrolled in the TOUCH prescribing program.
  4. Recent MRI as part of the TOUCH prescribing program.
  5. Patient must be between 18 and 55 years of age, inclusive.
  6. EDSS between 0 and 5.5, inclusive.
  7. Able to provide written informed consent.
  8. Capable of completing the fatigue (MFIS, FSS, and VAS-F) and cognition (ANAM) sessions.
  9. A baseline VAS-F average score of > 60.
  10. Patient must be naÃ-ve to TYSABRI® treatment.

Exclusion Criteria:

  1. Patients not enrolled in the TOUCH prescribing program.
  2. History or presence of progressive multifocal leukoencephalopathy (PML).
  3. Diagnosis of primary progressive MS (PPMS) or secondary progressive MS (SPMS) without relapses.
  4. Immunocompromised in the judgment of the investigator.
  5. Allergy or hypersensitivity to TYSABRI®.
  6. Prior history or current presence of a clinically significant medical illness or laboratory abnormality, including any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease, that, in the opinion of the investigator, would preclude the administration of TYSABRI®.
  7. Women pregnant, breast feeding, or planning to become pregnant and women who are not postmenopausal or surgically sterile, and unwilling to practice contraception.
  8. A baseline average VAS-F score of < 60.
  9. Problems with upper extremity dexterity that could preclude usage of a computer mouse.
  10. With educational completion below 8th grade school equivalent or non-fluent in English.
  11. Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464074


Locations
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United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006
United States, California
Research Site
Fresno, California, United States, 93720
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30327
United States, Idaho
Research Site
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Research Site
Evanston, Illinois, United States, 60201
Research Site
Lake Barrington, Illinois, United States, 60010
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46256
United States, Iowa
Research Site
West Des Moines, Iowa, United States, 50314
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40503
Research Site
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02135
Research Site
Lexington, Massachusetts, United States, 2421
United States, Michigan
Research Site
Farmington Hills, Michigan, United States, 48334
United States, New York
Research Site
Buffalo, New York, United States, 14203
Research Site
New York, New York, United States, 10003-3804
Research Site
Patchogue, New York, United States, 11772
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States, 27599
Research Site
High Point, North Carolina, United States, 27262
Research Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Research Site
Portland, Oregon, United States, 97225
United States, South Carolina
Research Site
Anderson, South Carolina, United States, 29621
United States, Tennessee
Research Site
Franklin, Tennessee, United States, 37064
Research Site
Knoxville, Tennessee, United States, 37934
Research Site
Nashville, Tennessee, United States, 37205
Research Site
Nashville, Tennessee, United States, 37212
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84103
Research Site
Salt Lake City, Utah, United States, 84108
United States, Washington
Research Site
Seattle, Washington, United States, 98195-6097
United States, West Virginia
Research Site
Charleston, West Virginia, United States, 25301
United States, Wisconsin
Research Site
Waukesha, Wisconsin, United States, 53188
Puerto Rico
Research Site
Guaynabo, Puerto Rico, 00969
Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
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Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00464074    
Other Study ID Numbers: 001-06-NAT
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: July 2011
Keywords provided by Biogen:
fatigue
Tysabri
cognition
Additional relevant MeSH terms:
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Multiple Sclerosis
Fatigue
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases