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Evaluation of Natalizumab for thE Relief of MS Associated FatiGue

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Phase: N/A

Status: Completed

Sponsored by: Biogen

Summary

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

Clinical Details

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 design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Visual Analog Scale for Fatigue (VAS-F)

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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 na├âĂĺ-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.

Locations and Contacts

Research Site, Guaynabo 00969, Puerto Rico

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 2421, United States

Research Site, Farmington Hills, Michigan 48334, United States

Research Site, Buffalo, New York 14203, United States

Research Site, New York, New York 10003-3804, 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 37212, United States

Research Site, Nashville, Tennessee 37205, United States

Research Site, Salt Lake City, Utah 84103, United States

Research Site, Salt Lake City, Utah 84108, United States

Research Site, Seattle, Washington 98195-6097, United States

Research Site, Charleston, West Virginia 25301, United States

Research Site, Waukesha, Wisconsin 53188, United States

Additional Information

Starting date: September 2007
Last updated: July 7, 2011

Page last updated: August 23, 2015

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