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

Multiple Sclerosis Clinical Trial

Official title:

A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00845338
• Other study ID #: 12331
• Secondary ID: 2006-002361-39
• Status: Terminated
• Phase: Phase 2
• First received: February 16, 2009
• Last updated: November 28, 2014
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Overactive Detrusor
• Sclerosis

Intervention

Drug:
• Darifenacin (BAY79-4998)
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in volume at first detrusor contraction as determined by urodynamics		At week 4	No
Secondary	Detrusor pressure at first contraction		At week 4	No
Secondary	Volume at first detectable leakage		At week 4	No
Secondary	Volume at 10/20/30/40 cm H2O		At week 4	No
Secondary	Compliance		At week 4	No
Secondary	Maximum cystometric bladder capacity		At week 4	No
Secondary	7-day micturition diary: Micturitions		At days 0, 14, 28	No
Secondary	7-day micturition diary: Urgency episodes		At days 0, 14, 28	No
Secondary	7-day micturition diary: Urge urinary incontinence episodes		At days 0, 14, 28	No

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