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A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function

NCT00818038 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2014-06-27

No results posted yet for this study

Summary

The primary objective of the study was to measure the change in bladder function as measured by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri treatment. Secondary objectives were to (i) measure change from baseline over 6 months of Tysabri treatment in the number of urinary incontinence episodes per participant per week, (ii) measure change from baseline over 6 months of Tysabri treatment in the number of micturitions per participant per day, (iii) measure change in The North American Research Committee on Multiple Sclerosis (NARCOMS) bladder/bowel subscale (PSB) scores from baseline over 6 months of Tysabri treatment and (iv) measure change in Incontinence Impact Questionnaire (IIQ)-7 scores from baseline over 6 months of Tysabri treatment.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

BG0002 (natalizumab)

Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00818038 on ClinicalTrials.gov