A Pilot, Multicenter, Double-blind, Placebo-controlled, Dose-escalation Study of the Safety and Efficacy of AGN-214868 in Patients with Idiopathic Overactive Bladder and Urinary Incontinence

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021718-41-NL

Enrollment

156

Registered

2010-09-24

Start date

2011-03-03

Completion date

Unknown

Last updated

2013-06-17

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

Conditions

To evaluate the safety and efficacy of AGN-214868 compared with placebo in the treatment of patients with idiopathic overactive bladder (IOAB) and urinary incontinence. MedDRA version: 14.1 Level: LLT Classification code 10059617 Term: Overactive bladder System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Endopeptidase Product Code: AGN-214868 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Not yet available CAS Number: N/A Current Sponsor code: AGN-214868 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female, 18 to 75 years of age IOAB with urinary incontinence Patient not adequately managed with previous anticholinergic agents = 24 micturitions during 3-day bladder diary = 6 urgency episodes during 3-day bladder diary = 1 urinary incontinence episode during 3-day bladder diary If female, must be of nonreproductive potential (see Section 4.6.1) If male, must be willing to use a double-barrier method of contraception during sexual intercourse with partners of reproductive potential or abstain from intercourse (see Section 4.6.2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Neurogenic overactive bladder A predominance of stress incontinence Previous botulinum toxin therapy of any serotype for any urologic condition Post void residual (PVR) urine volume of > 100 mL History or evidence of any condition, other than OAB, that may affect bladder function or may put the patient at risk or interfere with the integrity of the data

Design outcomes

Primary

Measure	Time frame
Main Objective: AGN-214868 has an acceptable safety profile in patients with IOAB AGN-214868 is more efficacious than placebo in reducing symptoms of IOAB ;Secondary Objective: Evaluate the pharmacokinetic profile of AGN214868 in patients suffering from idiopathic OAB Compare the safety and efficacy profiles of different doses of AGN214868 ;Primary end point(s): Primary efficacy measure: The change from study baseline at week 12 post treatment in the number of micturition episodes, with study baseline value defined as thenumber of micturition episodes prior to the treatment. Safety: Adverse events, serious adverse events, and serious medical events Physical examinations Vital signs Pregnancy testing Urine dipstick reagent test Central laboratory urine analysis (with urine culture/sensitivity, as applicable) Urine cytology Hematology and serum chemistry Kidney and bladder ultrasound PVR urine measurement 12-lead electrocardiogram (ECG) Blood samples for pharmacokinetic assessment Blood samples for immunogenicity analysis	—

Measure

Time frame

Main Objective: AGN-214868 has an acceptable safety profile in patients with IOAB AGN-214868 is more efficacious than placebo in reducing symptoms of IOAB ;Secondary Objective: Evaluate the pharmacokinetic profile of AGN214868 in patients suffering from idiopathic OAB Compare the safety and efficacy profiles of different doses of AGN214868 ;Primary end point(s): Primary efficacy measure: The change from study baseline at week 12 post treatment in the number of micturition episodes, with study baseline value defined as thenumber of micturition episodes prior to the treatment. Safety: Adverse events, serious adverse events, and serious medical events Physical examinations Vital signs Pregnancy testing Urine dipstick reagent test Central laboratory urine analysis (with urine culture/sensitivity, as applicable) Urine cytology Hematology and serum chemistry Kidney and bladder ultrasound PVR urine measurement 12-lead electrocardiogram (ECG) Blood samples for pharmacokinetic assessment Blood samples for immunogenicity analysis

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Countries

France, Netherlands, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026