E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Urinary incontinence caused by neurogenic detrusor overactivity |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029279 |
E.1.2 | Term | Neurogenic bladder |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety and maintenance of efficacy of each of 2 dosages of BOTOX (200 U or 300 U) injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient has successfully completed participation to the study 191622-515 or 191622-516 and the following criteria are met : The patient has completed at least 52 week in the previous study, with at least 12 week of follow up after the most recent treatment No more than 6 months have elapsed since the completion of the previous study 2. Written informed consent form has been obtained 3. Written authorization for the use and release of health and research study data has been obtained (only for US sites) 4. Written authorization for the protection and use of personal data has been obtained (only for EU sites) 5. Written documentation has been obtained in keeping with national and local data protection requirements, where applicable. 6. In the investigators opinion the patient is able to fulfill the study requirements, including diary completion and is available to attend all the study visits. 7. Current use or availability to use clean intermittent catheterization (CIC) for the bladder emptying (indwelling catheter is not allowed).A caregiver may perform the CIC. 8. Negative pregnancy test for female of childbearing potential 9. Weight equal or more than 50 kg (110 lb) |
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E.4 | Principal exclusion criteria |
1. Evidences of any pelvic or urological abnormalities, including, but not limited to : Interstitial cystitis in the investigators opinion Presence of bladder stones, including the ones detected during the preceding study Surgery or bladder disease other than detrusor overactivity , which can affect the bladder function (excepted than surgery performed more than one year before the screening for the preceding study for stress incontinence, uterine prolapse, rectocele or cystocele). 2. Preceding therapy with any serotype of botulinum toxin for any type of urological disease (except than treatment administered for the preceding study participation) 3. The patient was administered any serotype of botulinum toxin for any non urological disease within 12 weeks before the study entry/day 1. 4. The patient has been immunized for any serotype of botulinum toxin 5. Preceding or present diagnosis of prostate cancer 6. Preceding or present diagnosis of bladder cancer 7. Hemophilia or other clotting factors deficits or disorders that cause bleeding diathesis 8. Concurrent treatment or within 6 months from study entry/day 1 with intravescical capsaicin, resiniferatoxin, or any other intravesical treatment for overactive bladder 9. Present use or willing to use an implanted or non-implanted electrostimulation/neuromodulation device for treatment of overactive bladder or a baclofen pump. 10. Allergy or sensitivity to any components of the study medication, anesthetics or antibiotic or any other products associated to the treatment or to the general study procedures. 11. Medical conditions that that may expose the patient to a major risk as a result from the exposure to BOTOX, including myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis. 12. Pregnant women, nursing or who plans to become pregnant during the study or female of childbearing potential who are unable or not willing to use an adequate contraception method during the study. 13. Condition or situation which, in the investigators opinion, can expose the patient to considerable risks, confound the study results or meaningfully interfere with the patients participation to the study. 14. Patients who are participating or participated to another study on medicines or devices after exiting the191622-515 or 191622-516 study. 15. Any serious adverse event related to the study drug or to the study treatment during the 191622-515 or 191622-516 study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of urinary incontinence episodes, registered by the patient on the patient bladder diary during 3 consecutive days prior to each study visit. The change from baseline on daily average frequency of urinary incontinence episodes. The primary efficacy timepoint is week 6 after the first treatment in this study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |