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Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01743976
Recruitment Status : Terminated (Failure to recruit subjects)
First Posted : December 6, 2012
Results First Posted : November 18, 2020
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuropathic Pain
Interventions Drug: Donepezil
Drug: Placebo
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

Period Title: Overall Study
Started 2 3
Completed 2 3
Not Completed 0 0
Arm/Group Title Donepezil Placebo Total
Hide Arm/Group Description

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
44
(38 to 50)
52
(48 to 69)
50
(38 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
2
 100.0%
1
  33.3%
3
  60.0%
Male
0
   0.0%
2
  66.7%
2
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
3
 100.0%
5
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
 100.0%
2
  66.7%
4
  80.0%
White
0
   0.0%
1
  33.3%
1
  20.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
Hide Description A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

Overall Number of Participants Analyzed 2 3
Median (Full Range)
Unit of Measure: units on the scale
3.0
(1.3 to 4.7)
5.0
(4.6 to 5.5)
2.Primary Outcome
Title McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
Hide Description A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
Time Frame Week 8: last week of study drug treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

Overall Number of Participants Analyzed 2 3
Median (Full Range)
Unit of Measure: units on the scale
0.7
(0.1 to 1.6)
2.4
(0.1 to 5.4)
3.Primary Outcome
Title McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
Hide Description A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
Time Frame Week 10: last week of washout
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

Overall Number of Participants Analyzed 2 3
Median (Full Range)
Unit of Measure: units on the scale
0.4
(0.1 to 0.7)
2.8
(0.1 to 5.2)
4.Secondary Outcome
Title Average From Baseline Profile of Mood States-Short Form (POMS-SF) at 10 Weeks
Hide Description The questionnaire records total mood disturbance. The scale ranges from 0-100 with a greater number denoting a worse outcome.
Time Frame baseline, week 8 after baseline, and week 10 after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

Overall Number of Participants Analyzed 2 3
Median (Full Range)
Unit of Measure: Total score on POM-S scale
baseline
27
(26 to 28)
53
(23 to 71)
Week 8 after Baseline
25
(23 to 27)
24
(16 to 45)
Week 10 after Baseline
33
(27 to 40)
24
(15 to 38)
5.Secondary Outcome
Title Number of Days With Rescue Treatment
Hide Description Questionnaires detailing the amount of rescue pain medications will be completed twice daily.
Time Frame Days: baseline, week 8 after baseline, and week 10 after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

Overall Number of Participants Analyzed 2 3
Median (Full Range)
Unit of Measure: Days
Baseline
.5
(0 to 1)
0
(0 to 2)
Week 8 after Baseline
0
(0 to 0)
0
(0 to 6)
Week 10 after Baseline
0
(0 to 0)
0
(0 to 6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description

donepezil 5 mg every day

Donepezil: donepezil 5 mg once daily for 6 weeks

Placebo (sugar pill) every day

Placebo: placebo or sugar pill will be taken once daily for 6 weeks

All-Cause Mortality
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%) 
Early termination leading to small numbers of subjects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James C. Eisenach
Organization: Wake Forest School of Medicine
Phone: 336-716-4182
EMail: jimeisenach@gmail.com
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01743976    
Other Study ID Numbers: IRB00022107
R01NS057594 ( U.S. NIH Grant/Contract )
First Submitted: November 20, 2012
First Posted: December 6, 2012
Results First Submitted: September 22, 2020
Results First Posted: November 18, 2020
Last Update Posted: March 2, 2021