Trial record 1 of 301 for:    Open Studies | wake forest
Previous Study | Return to List | Next Study

Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James C. Eisenach, M.D., Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01743976
First received: November 20, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Neuropathic Pain
Drug: Donepezil
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    McGill short form pain questionnaire (SF MPQ)will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication.

    The visual analog scale (VAS) pain rating will serve as the study's primary outcome measure.



Other Outcome Measures:
  • Change from baseline disability measures at 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    The McGill short form pain questionnaire (SF MPQ) and the Profile of Mood States-Short Form (POMS-SF) will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication.

    Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.


  • Change from baseline psychometric measures at 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    The Profile of Mood States-Short Form (POMS-SF) will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication.

    Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.


  • Change from baseline global assessments at 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    The McGill short form pain questionnaire (SF MPQ) and the Profile of Mood States-Short Form (POMS-SF) will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication.

    Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.


  • Change from baseline rescue medication use at 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

    Questionnaires detailing the amount of rescue pain medications will be completed twice daily during the following time points: 2 weeks before taking study medication, 6 weeks during study medication, and 2 weeks after discontinuation of study medication.

    Outcome responses from the questionnaires will be examined using General Linear Models (GLM), examining for differences in group either at one time period or as a function of study phase, as appropriate.



Estimated Enrollment: 33
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743976

Contacts
Contact: Regina Curry, RN 336-716-4294 recurry@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157
Principal Investigator: James C Eisenach, M.D.         
Wake Forest Baptist Health Recruiting
Winston Salem, North Carolina, United States, 27295
Contact: Regina Curry, RN    336-716-4294    recurry@wakehealth.edu   
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: James C Eisenach, M.D. Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: James C. Eisenach, M.D., Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01743976     History of Changes
Other Study ID Numbers: 00022107, R01NS057594
Study First Received: November 20, 2012
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Wake Forest School of Medicine:
neuropathic pain
diabetic neuropathy
neuropathic pain after back surgery

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014