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

November 28, 2014 updated by: Bayer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • Emmendingen, Baden-Württemberg, Germany, 79312
      • Heidelberg, Baden-Württemberg, Germany, 69112
      • Lahr, Baden-Württemberg, Germany, 77933
      • Tübingen, Baden-Württemberg, Germany, 72076
      • Villingen-Schwenningen, Baden-Württemberg, Germany, 78054
    • Bayern
      • Planegg, Bayern, Germany, 82152
    • Hessen
      • Oberursel, Hessen, Germany, 61440
    • Nordrhein-Westfalen
      • Herne, Nordrhein-Westfalen, Germany, 44627
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
      • Mülheim, Nordrhein-Westfalen, Germany, 45468
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06112
    • Thüringen
      • Bad Berka, Thüringen, Germany, 99437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Darifenacin (BAY79-4998)
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in volume at first detrusor contraction as determined by urodynamics
Time Frame: At week 4
At week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Detrusor pressure at first contraction
Time Frame: At week 4
At week 4
Volume at first detectable leakage
Time Frame: At week 4
At week 4
Volume at 10/20/30/40 cm H2O
Time Frame: At week 4
At week 4
Compliance
Time Frame: At week 4
At week 4
Maximum cystometric bladder capacity
Time Frame: At week 4
At week 4
7-day micturition diary: Micturitions
Time Frame: At days 0, 14, 28
At days 0, 14, 28
7-day micturition diary: Urgency episodes
Time Frame: At days 0, 14, 28
At days 0, 14, 28
7-day micturition diary: Urge urinary incontinence episodes
Time Frame: At days 0, 14, 28
At days 0, 14, 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 16, 2009

First Submitted That Met QC Criteria

February 16, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 28, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12331
  • 2006-002361-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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