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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00845338
Recruitment Status : Terminated (The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.)
First Posted : February 18, 2009
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):

February 16, 2009
February 18, 2009
December 2, 2014
February 2007
October 2007   (Final data collection date for primary outcome measure)
Change from baseline in volume at first detrusor contraction as determined by urodynamics [ Time Frame: At week 4 ]
Same as current
Complete list of historical versions of study NCT00845338 on Archive Site
  • Detrusor pressure at first contraction [ Time Frame: At week 4 ]
  • Volume at first detectable leakage [ Time Frame: At week 4 ]
  • Volume at 10/20/30/40 cm H2O [ Time Frame: At week 4 ]
  • Compliance [ Time Frame: At week 4 ]
  • Maximum cystometric bladder capacity [ Time Frame: At week 4 ]
  • 7-day micturition diary: Micturitions [ Time Frame: At days 0, 14, 28 ]
  • 7-day micturition diary: Urgency episodes [ Time Frame: At days 0, 14, 28 ]
  • 7-day micturition diary: Urge urinary incontinence episodes [ Time Frame: At days 0, 14, 28 ]
Same as current
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Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity
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
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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Overactive Detrusor
Drug: Darifenacin (BAY79-4998)
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days
Experimental: Arm 1
Intervention: Drug: Darifenacin (BAY79-4998)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2007
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2006-002361-39 ( EudraCT Number )
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Study Director: Bayer Study Director Bayer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP