Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

Bayer

Status and phase: Terminated; Phase 2

Conditions: Multiple Sclerosis; Overactive Detrusor

Treatments: Drug: Darifenacin (BAY79-4998)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845338

12331

2006-002361-39 (EudraCT Number)

Details and patient eligibility

About

The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with multiple sclerosis for at least 6 months
• Neurogenic detrusor overactivity without DSD
• Symptoms of OAB
• Patients capable of completing the bladder diary
• Patients capable of independent toileting
• Patients able to swallow the study medication in accordance to the protocol
• Body Mass Index >/= 18,8 kg/qm and </= 35,0 kg/qm
• documented, dated, written informed consent

Exclusion criteria

• Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2
• Participation in a bladder-training program
• Low compliance bladder (Compliance <20 mL/cm H2O)
• DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
• Indwelling catheter or intermittent self-catheterization
• Patience with post-void residual (PVR) urinary volume > 200 mL at baseline
• Urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
• Clinically predominant and bothersome stress urinary incontinence
• Neurological diseases other than multiple sclerosis affecting urinary bladder function
• Any urogenital surgery within 12 month prior to Visit 1
• 17 Additional Exclusion Criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Darifenacin (BAY79-4998)