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Multiple SclerosisTysexNCT01455220

The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis

A study testing Tysabri ® (Natalizumab) in people with Multiple Sclerosis, run by University of South Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if sexual dysfunction symptoms and quality of life measures in patients with Multiple Sclerosis may be improved in patients that are prescribed Tysabri. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Tysabri ® (Natalizumab)
Type of treatment
Injection or infusion
How many people
45 participants
Where
1 siteUnited States
Study dates
Jan 2011to Oct 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
  • Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
  • Men and Women between 18 and 60 years of age
  • Must have EDSS less than or equal to 5.5 at baseline
  • Must be able to walk at least 100m without assistive devices
  • Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
Show all 14Show fewer
  • Must have a recent MRI (within 1 year from baseline)
  • Must satisfy the locally approved therapeutic indications for TYSABRI
  • Must be stable in disability for at least 30 days prior to enrollment to the study
  • Must be Natalizumab naïve
  • Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
  • Must be on a stable regimen of all symptomatic medications for Multiple Sclerosis especially those that could interfere with sexual function (specifically anti-cholinergics, anti-hypertensives, etc.) for at least 30 days prior to the enrollment.
  • Must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing.
  • Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN and GA) while being treated with Natalizumab during the study

Who cannot join

  • Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
  • Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
  • Men and Women between 18 and 60 years of age
  • Must have EDSS less than or equal to 5.5 at baseline
  • Must be able to walk at least 100m without assistive devices
  • Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
Show all 14Show fewer
  • Must have a recent MRI (within 1 year from baseline)
  • Must satisfy the locally approved therapeutic indications for TYSABRI
  • Must be stable in disability for at least 30 days prior to enrollment to the study
  • Must be Natalizumab naïve
  • Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
  • Must be on a stable regimen of all symptomatic medications for Multiple Sclerosis especially those that could interfere with sexual function (specifically anti-cholinergics, anti-hypertensives, etc.) for at least 30 days prior to the enrollment.
  • Must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing.
  • Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN and GA) while being treated with Natalizumab during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Florida, Frank and Carol Morsani Center

    Tampa, Florida, 33612

Other trials in United States

About this study

The purpose of this study is to determine if sexual dysfunction symptoms and quality of life measures in patients with Multiple Sclerosis may be improved in patients that are prescribed Tysabri.

Read the detailed description

Patients will be naive to Tysabri at the baseline for this study then their sexual dysfunction, fatigue, and quality of life measures will be measured using scaled questionnaires.

Being tested
Tysabri ® (Natalizumab)
Keywords
Multiple Sclerosis, Sexual Dysfunction, Quality of Life
Medical subject headings
Multiple Sclerosis, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tysabri ® (Natalizumab)Drug

    IV, monthly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )

    Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score.

    Measured: Baseline, 6 months

Secondary outcomes (3)

  1. Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))

    Change in composite score in the sexual function subscale of the Multiple Sclerosis Quality of Life (MSQOL-54) over 6 months of Natalizumab treatment. Minimum score of 0 and max score of 100. A higher score indicates a more positive outcome (less sexual dysfunction).

    Measured: Baseline, 6 months

  2. Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))

    Change in score on the Functional Assessment of MS (FAMS) questionnaire.The FAMS consists of 44 scored items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional well being (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social well being (seven items). Minimum score of 0 to max score of 176. A higher scores indicates positive (better) functional health related quality.

    Measured: Baseline, 6 months

  3. Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))

    Change in score on the Multiple Sclerosis Quality of Life (MSQOL-54) from end of study compared to baseline. The MSQOL-54 is a 54-item quality of life questionnaire that has general, as well as, MS specific questions covered in 6 sub-categories (mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being). Minimum score of 0 to maximum score of 100. Overall quality of life is calculated by averaging question 53 and 54. The sub-scales( mental and physical health) are on a weighted scale. Sets of questions are totaled and divided by the number of questions in each section then that section total is multiplied by a weighted value. Then all weighted values are summed for all relevant question sections for that subscale to compute a composite score for both mental health and physical health. A higher score, indicates a higher perceived quality of life for the patient. A lower scorer indicates poorer quality of life impacted by MS.

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455220
Sponsor's protocol ID
US-TYS-10-10057
Acronym
Tysex
Status last verified
Feb 2017
First submitted
10 Oct 2011
Last updated
31 Mar 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tysabri ® (Natalizumab) in people with Multiple Sclerosis, run by University of South Florida at 1 site in United States.

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 14 inclusion and 14 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01455220.

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 31 Mar 2017.

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