Patients with marked bladder dysfunction as a result of secondary progressive multiple sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in this double-blind crossover study.
Treatment periods of 4 weeks' duration are separated by a 6 week wash-out phase. After 14 weeks of randomised therapy there is a 38 week period of "open-label" AIMSPRO treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
1.0ml solution for subcutaneous injection (4.5mg total protein / ml) twice weekly for 4 weeks
Royal Free Hospital Hampstead NHS Trust
London, United Kingdom
Change in average voided volume
The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in average 24-hour frequency
The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in visual acuity and colour vision
Employs logMAR based and Farnsworth-Munsell 100 Hue testing. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in average 24-hour incontinence
The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in urgency score
The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in I-QOL score
The Incontinence - Quality of Life questionnaire is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
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Change in Whittington Urgency Score
The Whittington Urgency Score is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in Kurtzke EDS
The Kurtzke EDS assessment is undertaken at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in MSIS-29
The Multiple Sclerosis Impact Scale is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in MS FC
The The Multiple Sclerosis Functional Composite assessment is undertaken at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks
Change in MS WS
The Multiple Sclerosis Walking Scale is assessed at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.
Time frame: At 0, 4, 10 and 14 weeks