NCT00818038

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

Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	BG0002 (natalizumab)	Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-01-07
• Last updated: 2014-06-27