Study Stopped
The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.
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
2 other identifiers
interventional
7
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-sclerosis
Started Feb 2007
Shorter than P25 for phase_2 multiple-sclerosis
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 16, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedDecember 2, 2014
November 1, 2014
8 months
February 16, 2009
November 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in volume at first detrusor contraction as determined by urodynamics
At week 4
Secondary Outcomes (8)
Detrusor pressure at first contraction
At week 4
Volume at first detectable leakage
At week 4
Volume at 10/20/30/40 cm H2O
At week 4
Compliance
At week 4
Maximum cystometric bladder capacity
At week 4
- +3 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (15)
Unknown Facility
Emmendingen, Baden-Wurttemberg, 79312, Germany
Unknown Facility
Heidelberg, Baden-Wurttemberg, 69112, Germany
Unknown Facility
Lahr, Baden-Wurttemberg, 77933, Germany
Unknown Facility
Tübingen, Baden-Wurttemberg, 72076, Germany
Unknown Facility
Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany
Unknown Facility
Planegg, Bavaria, 82152, Germany
Unknown Facility
Hamburg, Hamburg, 20246, Germany
Unknown Facility
Oberursel, Hesse, 61440, Germany
Unknown Facility
Herne, North Rhine-Westphalia, 44627, Germany
Unknown Facility
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
Unknown Facility
Mülheim, North Rhine-Westphalia, 45468, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, 55131, Germany
Unknown Facility
Halle, Saxony-Anhalt, 06112, Germany
Unknown Facility
Berlin, State of Berlin, 10115, Germany
Unknown Facility
Bad Berka, Thuringia, 99437, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2009
First Posted
February 18, 2009
Study Start
February 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
December 2, 2014
Record last verified: 2014-11