E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Urinary Bladder, Neurogenic |
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E.1.1.1 | Medical condition in easily understood language |
Neurogenic Detrusor Overactivity |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
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 |
Incidence of adverse events Change in visual acuity from baseline Change in accommodation from baseline Change in cognitive function from baseline by the Child Behavior Checklist and Grooved Pegboard Test Change in blood pressure from baseline Change in temperature from baseline Change in pulse rate from baseline Incidence of urinary tract infection Change in clinical laboratory (hematology) from baseline Change in clinical laboratory (chemistry) from baseline Change in clinical laboratory (urinalysis) from baseline Change in post-void residual volume from baseline
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E.2.2 | Secondary objectives of the trial |
Change in maximum cystometric bladder capacity (Urodynamics assessment) from baseline Change in detrusor pressure at maximum bladder capacity (Urodynamics assessment) Presence of involuntary detrusor contractions (Urodynamics assessment) Change in bladder volume at first involuntary detrusor contraction (Urodynamics assessment) from baseline Change in bladder compliance (Urodynamics assessment) from baseline Change in mean number of micturitions and/or catheterizations/24 hours from baseline Change in mean number of incontinence episodes/24 hours from baseline Change in mean urgency episodes/24 hours from baseline, if applicable Change in mean volume voided per micturition or mean volume per catheterization from baseline |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who completed 24 week treatment and all visit procedures in the precedent Study A0221047 |
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E.4 | Principal exclusion criteria |
Subjects who had major protocol violation (as determined by the Sponsor) in Study A0221047 Concomitant medications which may increase the risk to subjects or confound study results Other medical conditions which may increase the risk to subjects or confound study results |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of adverse events Change in visual acuity from baseline Change in accommodation from baseline Change in cognitive function from baseline by the Child Behavior Checklist and Grooved Pegboard Test Change in blood pressure from baseline Change in temperature from baseline Change in pulse rate from baseline Incidence of urinary tract infection Change in clinical laboratory (hematology) from baseline Change in clinical laboratory (chemistry) from baseline Change in clinical laboratory (urinalysis) from baseline Change in post-void residual volume from baseline |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change in maximum cystometric bladder capacity (Urodynamics assessment) from baseline Change in detrusor pressure at maximum bladder capacity (Urodynamics assessment) Presence of involuntary detrusor contractions (Urodynamics assessment) Change in bladder volume at first involuntary detrusor contraction (Urodynamics assessment) from baseline Change in bladder compliance (Urodynamics assessment) from baseline Change in mean number of micturitions and/or catheterizations/24 hours from baseline Change in mean number of incontinence episodes/24 hours from baseline Change in mean urgency episodes/24 hours from baseline, if applicable Change in mean volume voided per micturition or mean volume per catheterization from baseline |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 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 | 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 | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA 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.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |