Trial Outcomes & Findings for Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial (NCT NCT00863551)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Day 10, Hour 5

Results posted on

2016-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Trospium Chloride Extended Release, 60 mg Trospium Chloride Extended Release, 60 mg
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trospium Chloride Extended Release, 60 mg n=12 Participants Trospium Chloride Extended Release, 60 mg
Age, Continuous	68 years n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 10, Hour 5

Population: Intent-to-treat, which included all patients who started the study.

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

Outcome measures

Outcome measures
Measure	Trospium Chloride Extended Release, 60 mg n=12 Participants Trospium Chloride Extended Release, 60 mg
Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5	NA Picograms per milliliter (pg/mL) Standard Deviation NA The data were below the limit of quantitation (BLQ).

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-treat, which included all patients who started the study.

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).

Outcome measures

Outcome measures
Measure	Trospium Chloride Extended Release, 60 mg n=12 Participants Trospium Chloride Extended Release, 60 mg
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 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-treat, which included all patients who started the study.

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).

Outcome measures

Outcome measures
Measure	Trospium Chloride Extended Release, 60 mg n=12 Participants Trospium Chloride Extended Release, 60 mg
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 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.

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.

Outcome measures

Outcome measures
Measure	Trospium Chloride Extended Release, 60 mg n=12 Participants Trospium Chloride Extended Release, 60 mg
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 Percentage of Subjects Due to technical problems associated with the administration of the test, the results were invalid.

SECONDARY outcome

Timeframe: Day 10

Population: Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.

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.

Outcome measures

Outcome measures
Measure	Trospium Chloride Extended Release, 60 mg n=12 Participants Trospium Chloride Extended Release, 60 mg
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 Percentage of Subjects Due to technical problems associated with the administration of the test, the results were invalid.

Adverse Events

Trospium Chloride Extended Release, 60 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Trospium Chloride Extended Release, 60 mg n=12 participants at risk Trospium Chloride Extended Release, 60 mg
Nervous system disorders Headache	58.3% 7/12
Gastrointestinal disorders Nausea	25.0% 3/12
Gastrointestinal disorders Vomiting	25.0% 3/12
Gastrointestinal disorders Constipation	16.7% 2/12
Gastrointestinal disorders Dry Mouth	16.7% 2/12
Gastrointestinal disorders Flatulence	16.7% 2/12
Musculoskeletal and connective tissue disorders Low back pain	16.7% 2/12
Skin and subcutaneous tissue disorders Folliculitis	8.3% 1/12
General disorders Change in taste	8.3% 1/12
Metabolism and nutrition disorders Increased appetite	8.3% 1/12
Psychiatric disorders Anxiety	8.3% 1/12

Additional Information

Vice President, Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER