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
| Registry | NCT00845338 |
|---|---|
| Status | Terminated - The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects. |
| Phase | Phase 2 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 7 (Actual) |
| Sponsor | Bayer (Industry) |
| Conditions | Multiple Sclerosis, Overactive Detrusor |
| Interventions | Darifenacin (BAY79-4998) (Drug) |
| Dates | start 2007-02-01, primary completion 2007-10-01, completion 2007-10-01, first posted 2009-02-18, last updated 2014-12-02 |
| Locations | 15 sites in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Sclerosis All trials for Overactive Detrusor All trials of Darifenacin (BAY79-4998)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1 | Experimental | Drug: Darifenacin (BAY79-4998) |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Emmendingen, Baden-Wurttemberg | Germany | ||
| Heidelberg, Baden-Wurttemberg | Germany | ||
| Lahr, Baden-Wurttemberg | Germany | ||
| Tübingen, Baden-Wurttemberg | Germany | ||
| Villingen-Schwenningen, Baden-Wurttemberg | Germany | ||
| Planegg, Bavaria | Germany | ||
| Hamburg, Free and Hanseatic City of Hamburg | Germany | ||
| Oberursel, Hesse | Germany | ||
| Herne, North Rhine-Westphalia | Germany | ||
| Mönchengladbach, North Rhine-Westphalia | Germany | ||
| Mülheim, North Rhine-Westphalia | Germany | ||
| Mainz, Rhineland-Palatinate | Germany | ||
| Halle, Saxony-Anhalt | Germany | ||
| Berlin, State of Berlin | Germany | ||
| Bad Berka, Thuringia | Germany |