Trial Outcomes & Findings for Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain (NCT NCT01743976)
NCT ID: NCT01743976
Last Updated: 2021-03-02
Results Overview
A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
baseline
Results posted on
2021-03-02
Participant Flow
Participant milestones
| Measure |
Donepezil
donepezil 5 mg every day
Donepezil: donepezil 5 mg once daily for 6 weeks
|
Placebo
Placebo (sugar pill) every day
Placebo: placebo or sugar pill will be taken once daily for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Donepezil
n=2 Participants
donepezil 5 mg every day
Donepezil: donepezil 5 mg once daily for 6 weeks
|
Placebo
n=3 Participants
Placebo (sugar pill) every day
Placebo: placebo or sugar pill will be taken once daily for 6 weeks
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
52 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselineA greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
Outcome measures
| Measure |
Donepezil
n=2 Participants
donepezil 5 mg every day
Donepezil: donepezil 5 mg once daily for 6 weeks
|
Placebo
n=3 Participants
Placebo (sugar pill) every day
Placebo: placebo or sugar pill will be taken once daily for 6 weeks
|
|---|---|---|
|
McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
|
3.0 units on the scale
Interval 1.3 to 4.7
|
5.0 units on the scale
Interval 4.6 to 5.5
|
PRIMARY outcome
Timeframe: Week 8: last week of study drug treatmentA greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
Outcome measures
| Measure |
Donepezil
n=2 Participants
donepezil 5 mg every day
Donepezil: donepezil 5 mg once daily for 6 weeks
|
Placebo
n=3 Participants
Placebo (sugar pill) every day
Placebo: placebo or sugar pill will be taken once daily for 6 weeks
|
|---|---|---|
|
McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
|
0.7 units on the scale
Interval 0.1 to 1.6
|
2.4 units on the scale
Interval 0.1 to 5.4
|
PRIMARY outcome
Timeframe: Week 10: last week of washoutA greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
Outcome measures
| Measure |
Donepezil
n=2 Participants
donepezil 5 mg every day
Donepezil: donepezil 5 mg once daily for 6 weeks
|
Placebo
n=3 Participants
Placebo (sugar pill) every day
Placebo: placebo or sugar pill will be taken once daily for 6 weeks
|
|---|---|---|
|
McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
|
0.4 units on the scale
Interval 0.1 to 0.7
|
2.8 units on the scale
Interval 0.1 to 5.2
|
SECONDARY outcome
Timeframe: baseline, week 8 after baseline, and week 10 after baselineThe questionnaire records total mood disturbance. The scale ranges from 0-100 with a greater number denoting a worse outcome.
Outcome measures
| Measure |
Donepezil
n=2 Participants
donepezil 5 mg every day
Donepezil: donepezil 5 mg once daily for 6 weeks
|
Placebo
n=3 Participants
Placebo (sugar pill) every day
Placebo: placebo or sugar pill will be taken once daily for 6 weeks
|
|---|---|---|
|
Average From Baseline Profile of Mood States-Short Form (POMS-SF) at 10 Weeks
baseline
|
27 Total score on POM-S scale
Interval 26.0 to 28.0
|
53 Total score on POM-S scale
Interval 23.0 to 71.0
|
|
Average From Baseline Profile of Mood States-Short Form (POMS-SF) at 10 Weeks
Week 8 after Baseline
|
25 Total score on POM-S scale
Interval 23.0 to 27.0
|
24 Total score on POM-S scale
Interval 16.0 to 45.0
|
|
Average From Baseline Profile of Mood States-Short Form (POMS-SF) at 10 Weeks
Week 10 after Baseline
|
33 Total score on POM-S scale
Interval 27.0 to 40.0
|
24 Total score on POM-S scale
Interval 15.0 to 38.0
|
SECONDARY outcome
Timeframe: Days: baseline, week 8 after baseline, and week 10 after baselineQuestionnaires detailing the amount of rescue pain medications will be completed twice daily.
Outcome measures
| Measure |
Donepezil
n=2 Participants
donepezil 5 mg every day
Donepezil: donepezil 5 mg once daily for 6 weeks
|
Placebo
n=3 Participants
Placebo (sugar pill) every day
Placebo: placebo or sugar pill will be taken once daily for 6 weeks
|
|---|---|---|
|
Number of Days With Rescue Treatment
Baseline
|
.5 Days
Interval 0.0 to 1.0
|
0 Days
Interval 0.0 to 2.0
|
|
Number of Days With Rescue Treatment
Week 8 after Baseline
|
0 Days
Interval 0.0 to 0.0
|
0 Days
Interval 0.0 to 6.0
|
|
Number of Days With Rescue Treatment
Week 10 after Baseline
|
0 Days
Interval 0.0 to 0.0
|
0 Days
Interval 0.0 to 6.0
|
Adverse Events
Donepezil
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place