Phase 4
N=12
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Elderly · Pharmacokinetics · Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00863551 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5 — NA Picograms per milliliter (pg/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trospium Chloride (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5 |
NA | — |
| SECONDARY Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose |
100 | — |
| SECONDARY Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose |
91.7 | — |
| SECONDARY Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose |
NA | — |
| SECONDARY Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose |
NA | — |
Summary
This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.
Eligibility Criteria
Inclusion Criteria
- Male or female, 65-75 years of age without evidence of memory impairment
- Subject has overactive bladder symptoms but otherwise healthy
- Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
- Weight within normal range
- Ability to follow study instructions and likely to complete all required visits
Exclusion Criteria
- Residual urine within bladder greater than 4 ounces
- Moderate or severe memory impairment
- Bleeding disorder
- Blood-thinning agents
- Concurrent overactive bladder medication
- Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
- Chronic kidney failure
- Abdominal bypass surgery for obesity
Data sourced from ClinicalTrials.gov (NCT00863551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.