Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain
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|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
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: Donepezil Drug: Placebo||Phase 4|
Investigators are currently examining in the laboratory the mechanisms which lead to sprouting of noradrenergic fibers in the spinal cord in models of chronic pain as well as the mechanisms that lead to a novel noradrenergic - cholinergic circuit in the spinal cord. In addition to examining the circumstances which generate this increased capacity for analgesia and the mechanisms by which they occur, investigators will test in this protocol whether approved and experimental treatments for neuropathic pain exploit this increased capacity.
This study is in patients with neuropathic pain taking gabapentin or pregabalin, and will test the clinical relevance of these preclinical data by comparing placebo to the cholinesterase inhibitor. Investigators focus not only on mechanistic hypotheses in the laboratory studies, but also on practical applications, using clinically approved drugs, including gabapentin and pregabalin to activate noradrenergic activity and donepezil (Aricept®), approved for the treatment of Alzheimer's dementia, but not previously tested to treat neuropathic pain, to inhibit cholinesterase. Each of these drugs may act by mechanisms in addition to those involved in descending noradrenergic inhibition, but investigators hypothesize that the therapeutic strength of their combination relies heavily on this cascade engendered by noradrenergic sprouting and altered α2-adrenoceptor function. The proposed studies will provide critical tests of this hypothesis and critical information to guide more effective clinical therapy of neuropathic pain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 23, 2013|
|Actual Study Completion Date :||October 23, 2013|
donepezil 5 mg every day
donepezil 5 mg once daily for 6 weeks
Other Name: Aricept
Placebo Comparator: Placebo
Placebo (sugar pill) every day
placebo or sugar pill will be taken once daily for 6 weeks
Other Name: sugar pill
- McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity [ Time Frame: baseline ]A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
- McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity [ Time Frame: Week 8: last week of study drug treatment ]A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
- McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity [ Time Frame: Week 10: last week of washout ]A greater number is considered a worse outcome. VAS Range (0-10) 0=No Pain 10=The worst pain imaginable.
- Average From Baseline Profile of Mood States-Short Form (POMS-SF) at 10 Weeks [ Time Frame: baseline, week 8 after baseline, and week 10 after baseline ]The questionnaire records total mood disturbance. The scale ranges from 0-100 with a greater number denoting a worse outcome.
- Number of Days With Rescue Treatment [ Time Frame: Days: baseline, week 8 after baseline, and week 10 after baseline ]Questionnaires detailing the amount of rescue pain medications will be completed twice daily.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743976
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Wake Forest Baptist Health|
|Winston-Salem, North Carolina, United States, 27295|
|Principal Investigator:||James C Eisenach, M.D.||Wake Forest University Health Sciences|