Trial Outcomes & Findings for Effect of Heat on Rivastigmine TDS Products (NCT NCT03915626)

Last Updated: 2022-04-04

Results Overview

Blood samples were obtained at the following time points: -60 min (before patch application) and then 2 h, 3 h, 4 h, 5 h, 5 h 15 min, 5 h 30 min, 5 h 45 min, 6 h, 6 h 15 min, 6 h 30 min, 6 h 45 min, 7 h, 7 h 30 min, 8 h, 8 h 30 min, 9 h, 9 h 15 min, 9 h 30 min, 10 h, 11 h, 12 h post patch administration.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

7 participants

Primary outcome timeframe

0-12 hours for each subject for each of the four study sessions

Results posted on

2022-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Rivastigmine RLD and Generic Patches Session 1: RLD patch worn for 9 hours, then at least one week wash out period, Session 2: Generic patch worn for 9 hours, then at least one week wash out period, Session 3: RLD patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min), then at least one week wash out period Session 4: Generic patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min)
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rivastigmine RLD and Generic Patches Session 1: RLD patch worn for 9 hours, then at least one week wash out period, Session 2: Generic patch worn for 9 hours, then at least one week wash out period, Session 3: RLD patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min), then at least one week wash out period Session 4: Generic patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min)
Overall Study study was halted due to COVID-19; once started again volunteer could no longer participate	1

Baseline Characteristics

Effect of Heat on Rivastigmine TDS Products

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivastigmine RLD and Generic Patches n=7 Participants Session 1: RLD patch worn for 9 hours, then at least one week wash out period, Session 2: Generic patch worn for 9 hours, then at least one week wash out period, Session 3: RLD patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min), then at least one week wash out period Session 4: Generic patch worn for 9 hours includes 90 minute heat application (5 h-6 h 30 min)
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	28.57 years STANDARD_DEVIATION 4.43 • n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 0-12 hours for each subject for each of the four study sessions

Outcome measures

Outcome measures
Measure	RLD Patch n=6 Participants RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours Rivastigmine (RLD) transdermal patch: brand name patch	Generic Patch n=6 Participants generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours Rivastigmine (generic) transdermal patch: generic patch	RLD Patch With Heat n=6 Participants RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application Rivastigmine (RLD) transdermal patch: brand name patch	Generic Patch With Heat n=6 Participants generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application Rivastigmine (generic) transdermal patch: generic patch
Total Area Under the Curve (AUC) 0-12 Hours	19.99 ng*h/mL Standard Deviation 14.35	19.22 ng*h/mL Standard Deviation 11.41	19.22 ng*h/mL Standard Deviation 11.41	16.57 ng*h/mL Standard Deviation 9.66

Adverse Events

RLD Patch

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Generic Patch

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

RLD Patch With Heat

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Generic Patch With Heat

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RLD Patch n=7 participants at risk RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours Rivastigmine (RLD) transdermal patch: brand name patch	Generic Patch n=7 participants at risk generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours Rivastigmine (generic) transdermal patch: generic patch	RLD Patch With Heat n=6 participants at risk RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application Rivastigmine (RLD) transdermal patch: brand name patch	Generic Patch With Heat n=6 participants at risk generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application Rivastigmine (generic) transdermal patch: generic patch
Investigations Dizziness	0.00% 0/7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	16.7% 1/6 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.
Cardiac disorders Decreased heart rate	0.00% 0/7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	14.3% 1/7 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.
Cardiac disorders Increased heart rate	0.00% 0/7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	16.7% 1/6 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.
Cardiac disorders Decreased blood pressure	42.9% 3/7 • Number of events 3 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	14.3% 1/7 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	16.7% 1/6 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.
Cardiac disorders Increased blood pressure	14.3% 1/7 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	14.3% 1/7 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	16.7% 1/6 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.
Investigations SOMNOLENCE (SLEEPINESS)	0.00% 0/7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	16.7% 1/6 • Number of events 1 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	0.00% 0/6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.
Skin and subcutaneous tissue disorders ERYTHEMA (skin reddening)	100.0% 7/7 • Number of events 7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	100.0% 7/7 • Number of events 7 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	66.7% 4/6 • Number of events 6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.	100.0% 6/6 • Number of events 6 • Subjects were observed for the 12 hours during product administration and then were followed up with a phone call up to 72 h after product removal; ~4 days for each of the four study sessions.

Additional Information

Dr. Audra L. Stinchcomb

University of Maryland, Baltimore School of Pharmacy

Phone: 410-706-2646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place