Evaluation of Natalizumab for thE Relief of MS Associated FatiGue
ENER-G
Multi-center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects With Relapsing Forms of MS
1 other identifier
observational
89
2 countries
31
Brief Summary
This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2007
Typical duration for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2010
CompletedAugust 22, 2023
August 1, 2023
3 years
April 18, 2007
August 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale for Fatigue (VAS-F)
at three months after initiating treatment with TYSABRI®
Eligibility Criteria
multicenter clinic patients
You may qualify if:
- Diagnosis of relapsing forms of MS.
- Patients having an inadequate response to or unable to tolerate alternate MS therapies.
- Patient must be enrolled in the TOUCH prescribing program.
- Recent MRI as part of the TOUCH prescribing program.
- Patient must be between 18 and 55 years of age, inclusive.
- EDSS between 0 and 5.5, inclusive.
- Able to provide written informed consent.
- Capable of completing the fatigue (MFIS, FSS, and VAS-F) and cognition (ANAM) sessions.
- A baseline VAS-F average score of \> 60.
- Patient must be naÃ-ve to TYSABRI® treatment.
You may not qualify if:
- Patients not enrolled in the TOUCH prescribing program.
- History or presence of progressive multifocal leukoencephalopathy (PML).
- Diagnosis of primary progressive MS (PPMS) or secondary progressive MS (SPMS) without relapses.
- Immunocompromised in the judgment of the investigator.
- Allergy or hypersensitivity to TYSABRI®.
- 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®.
- Women pregnant, breast feeding, or planning to become pregnant and women who are not postmenopausal or surgically sterile, and unwilling to practice contraception.
- A baseline average VAS-F score of \< 60.
- Problems with upper extremity dexterity that could preclude usage of a computer mouse.
- With educational completion below 8th grade school equivalent or non-fluent in English.
- Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient is determined not suitable for study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (31)
Research Site
Phoenix, Arizona, 85006, United States
Research Site
Fresno, California, 93720, United States
Research Site
Atlanta, Georgia, 30327, United States
Research Site
Idaho Falls, Idaho, 83404, United States
Research Site
Evanston, Illinois, 60201, United States
Research Site
Lake Barrington, Illinois, 60010, United States
Research Site
Indianapolis, Indiana, 46256, United States
Research Site
West Des Moines, Iowa, 50314, United States
Research Site
Lexington, Kentucky, 40503, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Boston, Massachusetts, 02135, United States
Research Site
Lexington, Massachusetts, 02421, United States
Research Site
Farmington Hills, Michigan, 48334, United States
Research Site
Buffalo, New York, 14203, United States
Research Site
New York, New York, 10003, United States
Research Site
Patchogue, New York, 11772, United States
Research Site
Chapel Hill, North Carolina, 27599, United States
Research Site
High Point, North Carolina, 27262, United States
Research Site
Raleigh, North Carolina, 27607, United States
Research Site
Portland, Oregon, 97225, United States
Research Site
Anderson, South Carolina, 29621, United States
Research Site
Franklin, Tennessee, 37064, United States
Research Site
Knoxville, Tennessee, 37934, United States
Research Site
Nashville, Tennessee, 37205, United States
Research Site
Nashville, Tennessee, 37212, United States
Research Site
Salt Lake City, Utah, 84103, United States
Research Site
Salt Lake City, Utah, 84108, United States
Research Site
Seattle, Washington, 98195, United States
Research Site
Charleston, West Virginia, 25301, United States
Research Site
Waukesha, Wisconsin, 53188, United States
Research Site
Guaynabo, 00969, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2007
First Posted
April 20, 2007
Study Start
August 1, 2007
Primary Completion
July 31, 2010
Study Completion
July 31, 2010
Last Updated
August 22, 2023
Record last verified: 2023-08