Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

Ipsen

Status and phase: Completed; Phase 2

Conditions: Detrusor Muscle Hyperactivity

Treatments: Biological: Botulinum toxin type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01357980

2010-023210-31 (EudraCT Number)

Y-52-52120-155

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.

Enrollment: 47 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
• Inadequate response or refractory to anticholinergic medication
• Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
• Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit

Exclusion criteria

• Significant Baseline renal and/or urinary tract pathology
• Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 4 patient groups, including a placebo group

Dysport 750 U (15 injection sites)

Experimental group

Treatment:

Biological: Botulinum toxin type A

Placebo (15 injection sites)

Placebo Comparator group

Treatment:

Drug: Placebo

Dysport 750 U (30 injection sites)

Experimental group

Treatment:

Biological: Botulinum toxin type A

Placebo (30 injection sites)

Placebo Comparator group

Treatment:

Drug: Placebo