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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00845338

Enrollment

Registered

2009-02-18

Start date

2007-02-28

Completion date

2007-10-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Overactive Detrusor

Keywords

Darifenacin, Multiple Sclerosis, Open Label Study

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.

Interventions

DRUGDarifenacin (BAY79-4998)

Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026