Multiple Sclerosis Clinical Trial
— ENER-GOfficial title:
Multi-center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects With Relapsing Forms of MS
NCT number | NCT00464074 |
Other study ID # | 001-06-NAT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2007 |
Est. completion date | July 31, 2010 |
Verified date | August 2023 |
Source | Biogen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.
Status | Completed |
Enrollment | 89 |
Est. completion date | July 31, 2010 |
Est. primary completion date | July 31, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Research Site | Guaynabo | |
United States | Research Site | Anderson | South Carolina |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Buffalo | New York |
United States | Research Site | Chapel Hill | North Carolina |
United States | Research Site | Charleston | West Virginia |
United States | Research Site | Evanston | Illinois |
United States | Research Site | Farmington Hills | Michigan |
United States | Research Site | Franklin | Tennessee |
United States | Research Site | Fresno | California |
United States | Research Site | High Point | North Carolina |
United States | Research Site | Idaho Falls | Idaho |
United States | Research Site | Indianapolis | Indiana |
United States | Research Site | Knoxville | Tennessee |
United States | Research Site | Lake Barrington | Illinois |
United States | Research Site | Lexington | Massachusetts |
United States | Research Site | Lexington | Kentucky |
United States | Research Site | Louisville | Kentucky |
United States | Research Site | Nashville | Tennessee |
United States | Research Site | Nashville | Tennessee |
United States | Research Site | New York | New York |
United States | Research Site | Patchogue | New York |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Portland | Oregon |
United States | Research Site | Raleigh | North Carolina |
United States | Research Site | Salt Lake City | Utah |
United States | Research Site | Salt Lake City | Utah |
United States | Research Site | Seattle | Washington |
United States | Research Site | Waukesha | Wisconsin |
United States | Research Site | West Des Moines | Iowa |
Lead Sponsor | Collaborator |
---|---|
Biogen | Elan Pharmaceuticals |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale for Fatigue (VAS-F) | at three months after initiating treatment with TYSABRI® |
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