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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
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:
Based on laboratory studies, donepezil will improve pain relief more than placebo in patients with chronic neuropathic pain who are currently taking gabapentin or pregabalin.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Donepezil Drug: Placebo Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Donepezil
donepezil 5 mg every day
Drug: Donepezil
donepezil 5 mg once daily for 6 weeks
Other Name: Aricept

Placebo Comparator: Placebo
Placebo (sugar pill) every day
Drug: Placebo
placebo or sugar pill will be taken once daily for 6 weeks
Other Name: sugar pill




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of diabetic neuropathy or failed back syndrome with neuropathic symptoms
  • Age 18-80
  • Taking a stable dose of gabapentin or pregabalin

Exclusion Criteria:

  • Pregnant women or women of child-bearing potential not willing to practice a reliable form of birth control
  • Allergy to donepezil or other piperidine derivatives (including fentanyl, alfentanil, sulfentanil, remifentanyl, demerol, tramadol, loperamide, diphenoxylate, betaprodine, alphaprodine, ethopropazine, anileridine, piminodine, 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine(MPTP),loratadine, fexofenadine
  • Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases that, in the opinion of the investigator, would preclude patients from finishing the trial
  • Any person with pending litigation
  • A history of major psychosis requiring hospitalization within the last three years
  • Non-English speaking, illiterate, unable to comprehend consent
  • Lack of contact information
  • Uncontrolled narrow-angle glaucoma
  • Currently being treatment with thioridazine (Mellaril)
  • Patients taking opioids will be excluded if they are taking a dosage that exceeds an equivalent of 30 mg of morphine per day
  • Patients taking more than one regular (not rescue) medication for pain
  • Patients taking donepezil for dementia
  • Patients with a baseline pain score less than 2 (0-10 scale) or greater than 8 (0-10) will be excluded

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Wake Forest University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: James C Eisenach, M.D. Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences ( Wake Forest University ):
Informed Consent Form  [PDF] September 14, 2015

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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01743976    
Other Study ID Numbers: IRB00022107
R01NS057594 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2012    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: March 2, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
neuropathic pain
diabetic neuropathy
neuropathic pain after back surgery
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents