Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Elderly; Pharmacokinetics; Overactive Bladder	Drug: Trospium Chloride	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	April 2009
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	August 2009

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Trospium Chloride Extended Release, 60 mg; Trospium Chloride Extended Release, 60 mg	Drug: Trospium Chloride; Extended release, 60 mg, oral daily; Other Name: Sanctura XR™ 60 mg

Outcome Measures

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Primary Outcome Measures :

1. Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5 [ Time Frame: Day 10, Hour 5 ]
   Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.

Secondary Outcome Measures :

1. 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 [ Time Frame: Day 10 ]
   The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory).
2. 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 [ Time Frame: Day 10 ]
   The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory).
3. 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 [ Time Frame: Day 10 ]
   The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.
4. 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 [ Time Frame: Day 10 ]
   The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.

Eligibility Criteria

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Ages Eligible for Study:	65 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
Glendale, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:	Medical Director	Allergan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00863551 History of Changes
Other Study ID Numbers:	MA-SXR-09-001; SMART Trial ( Other Identifier: Allergan )
First Posted:	March 18, 2009
Results First Posted:	December 19, 2011
Last Update Posted:	February 26, 2016
Last Verified:	January 2016

Additional relevant MeSH terms:

Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Trospium chloride; Parasympatholytics; Autonomic Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents