NCT01228396

AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis

A Randomised, Double-blind, Placebo-controlled Study of AIMSPRO in Treating Bladder Dysfunction in Secondary Progressive Multiple Sclerosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Daval International Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Secondary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Hyperimmune caprine serum against HIV lysate	1.0ml solution for subcutaneous injection (4.5mg total protein / ml) twice weekly for 4 weeks

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-05-01
• Completion: 2012-03-01
• First posted: 2010-10-26
• Last updated: 2011-08-18

Locations

1 site across 1 country: United Kingdom