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

August 18, 2023 updated by: Biogen

Multi-center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects With Relapsing Forms of MS

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

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00969
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Research Site
    • California
      • Fresno, California, United States, 93720
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Research Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Research Site
      • Lake Barrington, Illinois, United States, 60010
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Research Site
    • Iowa
      • West Des Moines, Iowa, United States, 50314
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Research Site
      • Lexington, Massachusetts, United States, 02421
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
    • New York
      • Buffalo, New York, United States, 14203
        • Research Site
      • New York, New York, United States, 10003
        • Research Site
      • Patchogue, New York, United States, 11772
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Research Site
      • High Point, North Carolina, United States, 27262
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
    • Tennessee
      • 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
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Research Site
      • Salt Lake City, Utah, United States, 84108
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Research Site
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Research Site
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

multicenter clinic patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale for Fatigue (VAS-F)
Time Frame: at three months after initiating treatment with TYSABRI®
at three months after initiating treatment with TYSABRI®

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Actual)

July 31, 2010

Study Completion (Actual)

July 31, 2010

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimated)

April 20, 2007

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-06-NAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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