E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neurogenic & Idiopathic detrusor overactivity in the bladder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005046 |
E.1.2 | Term | Bladder incontinence |
E.1.2 | System Organ Class | 100000004857 |
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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 establish laboratory methods for detecting changes degrees of bladder stimulation via nerves following treatment with BOTOX in patients with urinary urgency incontinence due either to: neurological disease or of unknown origin. |
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E.2.2 | Secondary objectives of the trial |
To obtain initial results on the changes of urine and bladder markers role at 14 days after and at the time of clinical relapse (between 6-9 months) post treatment. The information obtained may be used in a future large-scale research study.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men and women aged between 18 and 75. The group with NDO will be comprised exclusively of patients with multiple sclerosis who are attending the Uro-Neurology clinics. The group of patients with IDO will be comprised of patients without neurological disease but with urodynamically proven DO who are attending the Uro-Neurology clinics. In both groups, patients who have failed to respond adequately to two different oral anti-cholinergic medications and remain in need of further measures to treat urgency incontinence. Willing and able to perform self-catheterisations if required post treatment, if not already doing so Willing to give written informed consent Willing to attend the necessary follow up visits On effective contraception if sexually active - oral contraceptive pill (>3 months use), condoms, intrauterine contraceptive device, depot injection
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E.4 | Principal exclusion criteria |
Patients with non-neurogenic DO and bladder outlet obstruction upon urodynamic investigation Presence of a low compliance bladder in the absence of DO Previous intra-detrusor BoNT/A injections within the last one year. Patients with known hypersensitivity to Botulinium toxin A or any of its exipients Pregnant or lactating women and those planning pregnancy Anticoagulant therapy (On Aspirin, Clopidogrel, Warfarin or other anti-coagulants) at the time of inclusion. On drugs that might interfere with neuromuscular transmission (e.g. Aminoglycosides) Pain thought to originate from the urinary tract Unsuitable past medical history e.g. frequent epilepsy, uncontrolled hypertension, severe coronary artery disease. Participation in a clinical trial involving an investigational product in the last 3 months
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in urine/bladder NGF levels and urothelial TRPV1 levels at 14 days after treatment, and at the time of documented clinical relapse (a variable time between 6-9 months post treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Other causes of detrusor overactivity, patients without detrusor overactivity |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |