Multiple SclerosisENER-GNCT00464074
Evaluation of Natalizumab for thE Relief of MS Associated FatiGue
An observational study of Multiple Sclerosis, run by Biogen at 31 sites in 2 countries.
Trial summary
This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 89 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 1 Aug 2007to 31 Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: multicenter clinic patients
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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®.
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- 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.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
Research Site
Anderson, South Carolina, 29621
Research Site
Atlanta, Georgia, 30327
Research Site
Boston, Massachusetts, 02135
Research Site
Buffalo, New York, 14203
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Charleston, West Virginia, 25301
Research Site
Evanston, Illinois, 60201
Research Site
Farmington Hills, Michigan, 48334
Research Site
Franklin, Tennessee, 37064
Research Site
Fresno, California, 93720
Research Site
High Point, North Carolina, 27262
Research Site
Idaho Falls, Idaho, 83404
Research Site
Indianapolis, Indiana, 46256
Research Site
Knoxville, Tennessee, 37934
Research Site
Lake Barrington, Illinois, 60010
Research Site
Lexington, Kentucky, 40503
Research Site
Lexington, Massachusetts, 02421
Research Site
Louisville, Kentucky, 40202
Research Site
Nashville, Tennessee, 37205
Research Site
Nashville, Tennessee, 37212
Research Site
New York, New York, 10003
Research Site
Patchogue, New York, 11772
Research Site
Phoenix, Arizona, 85006
Research Site
Portland, Oregon, 97225
Research Site
Raleigh, North Carolina, 27607
Research Site
Salt Lake City, Utah, 84103
Research Site
Salt Lake City, Utah, 84108
Research Site
Seattle, Washington, 98195
Research Site
Waukesha, Wisconsin, 53188
Research Site
West Des Moines, Iowa, 50314
About this study
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
This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.
Read the 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:
- 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:
- Modified Fatigue Impact Scale (MFIS)
- 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
- Conditions
- Multiple Sclerosis
- Keywords
- fatigue, Tysabri, cognition
- Medical subject headings
- Multiple Sclerosis, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Fatigue (VAS-F)
Measured: at three months after initiating treatment with TYSABRI®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study start1 Aug 2007
- Primary completion31 Jul 2010
- Study completion31 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464074
- Sponsor's protocol ID
- 001-06-NAT
- Acronym
- ENER-G
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2007
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00464074
- Acronym / sponsor ID
- ENER-G / 001-06-NAT
- Conditions
- Multiple Sclerosis
- Keywords
- fatigue, Tysabri, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 31 Jul 2010 (actual)
- Study completion
- 31 Jul 2010 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to study the effects of TYSABRI® treatment on fatigue and cognition in patients with relapsing forms of MS.
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:
- 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:
- Modified Fatigue Impact Scale (MFIS)
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- multicenter clinic patients
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale for Fatigue (VAS-F)
Time frame: at three months after initiating treatment with TYSABRI®
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Fatigue (VAS-F) (time frame: at three months after initiating treatment with TYSABRI®). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.