Trial Outcomes & Findings for The Effect of Donepezil on Sedation and Other Symptoms (NCT NCT00352664)

NCT ID: NCT00352664

Last Updated: 2016-05-09

Results Overview

Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing "not drowsy" and 10 representing "worst possible drowsiness."

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 27 participants
• Primary outcome timeframe: Baseline and Day 7
• Results posted on: 2016-05-09

Participant Flow

Patient Recruitment: 12/10/03 for first patient through 09/14/05 for last patient. All participants recruited at UT MD Anderson Cancer Center.

27 patients were enrolled, 7 dropped out prior to assessment and were excluded from the overall study. Due to early termination, patients were not randomized.

Participant milestones

Measure	Donepezil Oral Donepezil 5 mg daily x 7 days	Placebo Oral Placebo tablet daily x 7 days
Overall Study STARTED	27	0
Overall Study COMPLETED	20	0
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Measure	Donepezil Oral Donepezil 5 mg daily x 7 days	Placebo Oral Placebo tablet daily x 7 days
Overall Study Withdrawal by Subject	7	0

Baseline Characteristics

The Effect of Donepezil on Sedation and Other Symptoms

Baseline characteristics by cohort

Measure	Donepezil n=27 Participants Oral Donepezil 5 mg daily x 7 days	Placebo Oral Placebo tablet daily x 7 days	Total n=27 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	—	56 years n=5 Participants
Gender Female	18 participants n=5 Participants	—	18 participants n=5 Participants
Gender Male	9 participants n=5 Participants	—	9 participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	—	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 7

Population: Analysis was intention to treat (ITT), and population analyzed was that treated. Study closed early due to low patient accrual and insufficient supply of drug. No patients were randomized to Placebo Arm.

Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing "not drowsy" and 10 representing "worst possible drowsiness."

Outcome measures

Measure	Donepezil n=20 Participants Oral Donepezil 5 mg daily x 7 days	Placebo Oral Placebo tablet daily x 7 days
Sedation Mean Scores at 1-Week Baseline	6.44 Scores on a Scale Standard Deviation 1.2	—
Sedation Mean Scores at 1-Week Day 7	4.81 Scores on a Scale Standard Deviation 2.6	—

Adverse Events

Donepezil

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Donepezil n=20 participants at risk Oral Donepezil 5 mg daily x 7 days	Placebo Oral Placebo tablet daily x 7 days
Gastrointestinal disorders Nausea/vomiting	30.0% 6/20 • Number of events 6 • 4 years	— 0/0 • 4 years
Gastrointestinal disorders Diarrhea	25.0% 5/20 • Number of events 5 • 4 years	— 0/0 • 4 years
General disorders Anorexia	20.0% 4/20 • Number of events 4 • 4 years	— 0/0 • 4 years
General disorders Muscle Cramps	10.0% 2/20 • Number of events 2 • 4 years	— 0/0 • 4 years

Additional Information

Eduardo Bruera, MD / Professor

UT MD Anderson Cancer Center

Phone: 713-792-6084

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place