Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

NCT00863551 | Completed Phase 4 Results

• 2 other identifiers: MA-SXR-09-001SMART Trial
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Pharmacokinetics; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5

  Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.

  Day 10, Hour 5

Secondary Outcomes (4)

• 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

  Day 10

• 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

  Day 10

• 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

  Day 10

• 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

  Day 10

Study Arms (1)

Trospium Chloride Extended Release, 60 mg

EXPERIMENTAL

Trospium Chloride Extended Release, 60 mg

Drug: Trospium Chloride

Interventions

Trospium Chloride DRUG

Extended release, 60 mg, oral daily

Also known as: Sanctura XR™ 60 mg

Trospium Chloride Extended Release, 60 mg

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Glendale, California, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

trospium chloride

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to technical problems associated with the administration of the BVMT-R test, the results were invalid, therefore, results for Outcome Measures 4 and 5 are not presented.

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 18, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 26, 2016
• Results First Posted: December 19, 2011

Record last verified: 2016-01

Locations

US (1)