CLINICAL TRIALS PROFILE FOR ONABOTULINUMTOXINA
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All Clinical Trials for onabotulinumtoxina
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00439140 ↗ | Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder | Terminated | Allergan | Phase 3 | 2007-06-01 | This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis. |
| NCT00777803 ↗ | NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines | Completed | Merz Pharmaceuticals GmbH | Phase 3 | 2008-11-01 | NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines. |
| NCT00910520 ↗ | Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence | Completed | Allergan | Phase 3 | 2009-09-01 | The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence. |
| NCT00910845 ↗ | Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence | Completed | Allergan | Phase 3 | 2009-09-01 | The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence. |
| NCT01050114 ↗ | OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER | Unknown status | Christopher Patrick Smith | Phase 3 | 2013-08-01 | Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine). OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold. This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases. Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day. The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A |
| NCT01071096 ↗ | Calcitonin Gene-related Peptide Levels in Chronic Migraine | Completed | Allergan | Phase 4 | 2010-06-01 | Twenty patients will be enrolled in a 2-site, 7-month, double-blind study conducted to evaluate a reduction in headache days and attacks and calcitonin gene-related peptide (CGRP) levels in saliva following treatment with OnabotulinumtoxinA versus saline. Eligible patients will be randomized and receive injections of OnabotulinumtoxinA or Saline at Visit 1. Following 3 months plus a 1 month wash out, patients will receive cross-over injections at Visit 5. Patients will return for monthly visits and exit the study at Visit 8. Patients will collect saliva at monthly intervals and document in a daily headache diary throughout the study . |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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